onmedic news: de març 2014

dilluns, 31 de març del 2014

FDA wants your perspective on clinical trial demographic data

FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad - sharing news, background, announcements and other information about the work done at the FDA on behalf of the American public.

By: Jonca Bull, M.D.

When designing clinical trials, it is essential to test the safety and effectiveness of medical products in the people they are meant to treat. Although FDA's policies, guidances, and regulations reflect decades of agency efforts to foster the participation of diverse patient populations in clinical trials, more work is required.

Food & Drug Administration (FDA)

News Well, Blog, Food & Drug Administration (FDA), Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/QzFMNy

ACC 2014 Roundup: Study shows long-term benefits for some CRT-D patients

Seven-year results from Boston Scientific's MADIT-CRT trial show long-term benefits for some patients with mild heart failure.

Some patients with mild heart failure show significant, long-term benefits from cardiac-resynchronization therapy, according to the 7-year results from Boston Scientific's (NYSE:BSX) MADIT-CRT clinical trial presented at the American College of Cardiology's annual meeting over the weekend.

American College of Cardiology, Boston Scientific, Abbott Laboratories

News Well, Clinical Trials, ACC 2014, Bariatrics, Diabetes, Replacement Heart Valves, Stent Wars

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1oiHlOz

Major mismatch: 1 in 3 clinical trials reports inconsistent adverse events, researchers say

Researchers find that 1 in 3 studies reported on the federal ClinicalTrials.gov database posted different adverse event outcomes when publishing in medical journals.

1 in 5 trials posts inconsistent results in fed databases and med journals

A random sampling of clinical trials reported to the federal ClinicalTrials.gov database found that 1 in 3 had inconsistencies in their adverse event outcomes when compared with reports made to peer-reviewed medical journals, researchers said.

Annals of Internal Medicine

News Well, Clinical Trials, Research & Development

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1rYsAj6

ACC 2014: Sapien XT bests CoreValve in small head-to-head study

Edwards Lifesciences' Sapien XT replacement heart valve bests Medtronic's CoreValve in a small head-to-head study presented at the American College of Cardiology's annual conference.

American College of Cardiology, Edwards Lifesciences, Medtronic

News Well, ACC 2014, Replacement Heart Valves, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1pz9AFU

How sure can we be about Optisure?

St. Jude Medical announced the global launch of the Optisure family of ICD leads.

By Edward J. Schloss, MD

St. Jude Medical

News Well, Cardiac Rhythm Management

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1khYDp0

Hacking a solution for hydrocephalus… just not the one expected

Vector is Children's Hospital Boston's blog about research and innovation in pediatric and adult medicine. We report and comment on medical innovations and advances – from bench to bedside – touching on scientific, business and policy issues. Our ranks include science writers, physicians, lab researchers, market analysts and others inside and outside the hospital.

By Nancy Fliesler

Boston Children's Hospital

News Well, Vector Blog, Blog, Pediatrics

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1iRNlrU

Judge cuts Biolase board of directors | Medtech legal news for the week of Mar. 31, 2014

Here's a look at some of the top legal news stories for medical device companies this week.

UPDATE: Court cuts Biolase board, marketing VP under fire

March 24, 2014 by Arezu Sarvestani

Court halves Biolase board, marketing VP under fire

Alliant Enterprises, Biolase Technology Inc., Corporate Action Network, Dept. of Justice (DOJ), Ethicon Inc., European Commission, European Union, Intuitive Surgical Inc., Johnson & Johnson, Millennium Dental Technologies, Oracle Partners, Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Stryker Corp.

Legal News, News Well, Legal Roundup

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1dJQ3R9

divendres, 28 de març del 2014

Axonics raises $33M for its neuromodulation tech

Alfred Mann Foundation spinout Axonics Modulation Technologies raises nearly $33 million in a Series A round for its neuromodulation technology.

Axonics Modulation Technologies said it drummed up a $32.6 million Series A round for the neuromodulation technology it's developing to treat chronic pain and overactive bladder.

Irvine, Calif.-based Axonics said the round was led by Edmond de Rothschild Investment Partners and included NeoMed Management, Legend Capital and "a select group of private individuals."

Axonics Modulation Technologies, Vessix Vascular Inc.

News Well, Funding Roundup, Neuromodulation/Neurostimulation, Personnel

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1ftEUiK

PullClean handles hand sanitizing the easy way

Check out Altitute Medical's smart sanitizer dispenser, designed to be installed within the door handle itself.

Altitute Medical

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1o8Ap6p

Abbott wins FDA nod for Supera peripheral stent

Abbott says the FDA granted pre-market approval for its Supera stent for treating peripheral artery disease.

Abbott (NYSE:ABT) said the FDA granted pre-market approval for its Supera peripheral stent.

Abbott Park, Ill.-based Abbott said the stent is designed to conform to the shape of patients' blood vessels. The FDA approved the Supera device for treating occlusions in the superficial femoral artery and the proximal popliteal artery.

Food & Drug Administration (FDA), Abbott Laboratories

News Well, Peripheral Stents, Pre-Market Approval (PMA)

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1o8uRsD

Women scientists at FDA: A legacy to be proud of

By: Suzanne Junod, Ph.D.

This is National Women’s History Month, a good time to reflect on FDA’s history of advancing women as scientists and health professionals. This tradition began with FDA’s predecessor in the late 19th and early 20th centuries, the Bureau of Chemistry in the Department of Agriculture. Several early female FDA scientists came out of the University of Pennsylvania, one of the first universities in the country to offer women chemistry degrees in the late 19th century.

Food & Drug Administration (FDA)

News Well, Blog, Food & Drug Administration (FDA), Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1gJTDeA

Medtech cybersecurity by demand: Building groundswell among hospitals

Cybersecurity researchers want hospitals to join forces to drive demand for better digital security in medical devices.

Hospitals are growing increasingly interested in medical device digital security, and a pair of cybersecurity experts hope to consolidate those concerns into a groundswell.

Accuvant

News Well, Cybersecurity/Hacking, Health Information Technology, Hospital Care

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1g7evXu

Invendo Medical raised $28 million for its single-use colonoscopy system | Medtech funding stories for the week of Mar. 24, 2014

Here's a look at some of the top funding stories for medical device companies this week.

Invendo Medical raises $28M for single-use colonoscope

March 24, 2014 by Brad Perriello

360° Capital, Boston Children's Hospital, Invendo Medical, IsoRay, Neovasc Inc., TVM Capital, Veran Medical Technologies, Wellington Partners, Xeraya Capital

News Well, Funding Roundup

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1je6oh1

dijous, 27 de març del 2014

Terumo inks deal for Arterial Remodeling's bioresorbable stent

Terumo inks a structured deal for Arterial Remodeling Technologies' bioresorbable drug-eluting coronary stent.

Arterial Remodeling Technologies said it inked a deal with Terumo Corp. (TYO:4543) for its bioresorbable drug-eluting coronary stent that includes an exclusive buyout option.

Arterial Remodeling Technologies, Terumo Corp.

News Well, Bioabsorbable Stents, Drug-Eluting Stents, Mergers & Acquisitions, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1gFU3CJ

Neovasc raises $22.5M for cardiac implants

Neovasc plans to use its newly raised $22.5 million to further fund development efforts for its Neovasc Reducer refractory angina implant and Tiara transcatheter mitral valve.

Neovasc raises $22.4M for cardiac implants

Neovasc Inc.

News Well, Funding Roundup, Implants, Replacement Heart Valves, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1fnz5mP

Veran nears $5M fundraising goal for airway imaging

Veran Medical Technologies creeps ever nearer to its $5 million fundraising target in support of its SPiNDrive electromagnetic airway mapping system.

Missouri-based Veran Medical Technologies is on the verge of closing a $5 million funding round in support of its electromagnetic airway mapping system, regulatory filings show.

Veran Medical Technologies

News Well, Funding Roundup, Imaging, Oncology, Respiratory

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1fnmQqm

Baxter reveals plans to split pharma, medical products businesses

Baxter International says it plans to go the way of rivals Abbott and Covidien in splitting its pharmaceuticals and medical products businesses into separate companies.

AbbVie, Baxter International, Covidien, K-C Health Care, Kimberly-Clark Worldwide Inc., Mallinckrodt, Abbott Laboratories

News Well, Mergers & Acquisitions, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/NYVb7X

Brain structural imaging: Gleaning more with math

By Nancy Fliesler

Diffusion tensor imaging (DTI), a form of magnetic resonance imaging, has become popular in neuroscience. By analyzing the direction of water diffusion in the brain, it can reveal the organization of bundles of nerve fibers, or axons, and how they connect – providing insight on conditions such as autism.

Boston Children's Hospital

News Well, Vector Blog, Blog, Imaging, Neurological

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/P5DioI

Medicare maintains reimbursement rate for Abiomed heart pump | Medtech Wall Street news for the week of Mar. 24, 2014

Here's a look at some of the top Wall Street stories for medical device companies this week.

Abiomed jumps on Medicare reimbursement news

March 21, 2014 by Brad Perriello

Centers for Medicare and Medicaid Services (CMS), Corium, Haemonetics, Intuitive Surgical Inc., Presbia, Red Cross, Abiomed Inc.

News Well, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/P5Dggt

dimecres, 26 de març del 2014

Study: Biosense Webster's force-sensing catheters lower AF recurrence

Patients with atrial fibrillation may be less likely to have recurring symptoms following ablation treatment with force-sending catheters from Johnson & Johnson subsidiary Biosense Webster, researchers say.

BioSense Webster Inc., Johnson & Johnson

News Well, Clinical Trials, Ablation, Catheters

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/P1qnnF

Pentagon exercises $150M contract options with Philips, GE Healthcare

GE Healthcare and Philips Medical Systems land extensions worth $150 million of their contracts with the U.S. Defense Dept. for imaging and patient monitoring devices.

Philips Healthcare, U.S. Defense Dept., GE Healthcare

News Well, Imaging, Patient Monitoring

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1o10c0v

Medtronic details humanitarian sales to Syria, Cuba, Sudan

Medtronic details its humanitarian sales to Syria, Cuba and Sudan to the U.S. Securities & Exchange Commission.

The U.S. Securities & Exchange Commission closed its review of Medtronic's sales to strife-torn Syria and Sudan and to Cuba, which the medical device company said are made on a humanitarian basis and amount to a small fraction of its total business.

The SEC asked Medtronic in January to explain its business contacts in the 3 nations, which are flagged as state sponsors of terrorism and are subject to U.S. economic sanctions and assets controls.

Medtronic, Securities & Exchange Commission (SEC)

News Well, Exports

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/P0AOI7

Biolase board of directors cut by DE judge | Medtech personnel moves for the week of Mar. 24, 2014

Here's a look at some of the top personnel stories for medical device companies this week.

UPDATE: Court cuts Biolase board, marketing VP under fire

March 24, 2014 by Arezu Sarvestani

Becton Dickinson & Co., Biolase Technology Inc., Corning Inc., DJO Global Inc., Imaging Diagnostic Systems, Invacare Corp., Life Technologies Corp., LifeScience Alley, Millennium Dental Technologies, NinePoint Medical Inc., Oracle Partners, Prospect Venture Partners, RF Surgical Systems, Securities & Exchange Commission (SEC), Third Rock Ventures LLC, Unilife Corp.

News Well, Personnel, Personnel Moves, Personnel Roundup

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1llSa0b

What does Facebook's $2B Oculus buy bring to healthcare? | MassDevice.com On Call

The Oculus Rift virtual reality technology, just acquired by Facebook for a cool $2 billion, isn't just for video games; researchers are looking at the technology as a tool for diagnostics and rehabilitation.

MASSDEVICE ON CALL — New Facebook (NSDQ:FB) target Oculus VR may have some important offerings for the healthcare world, especially in imaging-based diagnostics and immersive rehabilitation therapy.

Facebook, Oculus VR

News Well, On Call, Diagnostics, Innovation, Mergers & Acquisitions, Rehabilitation Equipment

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1jua6FS

dimarts, 25 de març del 2014

EU launches investigation into pelvic mesh

The European Commission tasks an advisory panel with examining the safety of pelvic mesh products to treat stress urinary incontinence and pelvic organ prolapse.

The European Commission asked a scientific advisory panel to look into the safety of surgical procedures to treat urogynecological conditions using mesh products, which have embroiled their makers in tens of thousands of product liability lawsuits in the U.S.

The EU's executive body asked its Scientific Committee on Emerging and Newly Identified Health Risks for an opinion on the "safety of surgical meshes used in urogynecological surgery," according to the commission's request.

European Commission, European Union, Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)

Legal News, News Well, Gynecological

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1gWlXoo

Stryker, Alliant settle FCA beef for $1M

Stryker Corp. and Alliant Enterprises together paid more than $1 million to settle a federal lawsuit alleging that they overcharged the U.S. Veterans Affairs Dept. for medical equipment.

Stryker (NYSE:SYK) and Alliant Enterprises agreed to pay a collective $1 million but admitted no wrongdoing in settling a whistleblower lawsuit alleging that they overcharged the U.S. Veterans Affairs Dept. for medical equipment.

Alliant Enterprises, Stryker Corp.

Legal News, News Well, Durable Medical Equipment

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1gyb2H7

Israel's Medigus lands FDA win for new MUSE acid reflux treatment

Medigus wins FDA clearance for the next generation of its minimally invasive MUSE system for treating acid reflux through the mouth.

Israel-based Medigus lands FDA win for new MUSE acid reflux treatment

Israel-based Medigus (TLV:MDGS) won FDA clearance for the next generation of its MUSE technology, a minimally invasive technology for performing surgeries to treat acid reflux disease.

Medigus Ltd.

News Well, Regulatory/Clearance, 510(k), Endovascular, Food & Drug Administration (FDA), Minimally Invasive Surgery, Surgical

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1gyb3ea

Transcatheter Tech. touts no leakage at 6-months with Trinity TAVI

Transcatheter Technologies' touts zero instances of paravalvular leakage in 6-month pilot results for its Trinity transcatheter aortic valve implantation system.

TAVI: Transcatheter Tech. touts 6-month results for Trinity device

Transcatheter Technologies GmbH touted 6-month results from a pilot study of its Trinity transcatheter aortic valve implantation system, reporting no instances of valve leakage.

Transcatheter Technologies GmbH

News Well, Clinical Trials, Cardiac Implants, Replacement Heart Valves

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/NP6bVe

Diabetes: FDA warns Dexcom on adverse event reports

Dexcom says the FDA issued a warning letter over its reporting of adverse events associated with its continuous glucose monitors.

Dexcom Inc. (NSDQ:DXCM) said the FDA flagged its adverse event reporting system for not being compliant with new medical device reporting rules.

The federal watchdog agency issued a warning letter to San Diego-based Dexcom, which makes continuous glucose monitors for diabetics, after an inspection in November 2013, according to a press release.

DexCom Inc., Food & Drug Administration (FDA)

News Well, Diabetes, Regulatory/Compliance, Warning Letter

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1jqR96X

Medtech recalls nearly doubled in past 10 years | Medtech regulatory news for the week of Mar. 24, 2014

Here's a look at some of the top regulatory stories for medical device companies this week.

FDA: Medtech recalls up 97% since 2003, but that's a good thing

March 21, 2014 by Arezu Sarvestani

Avedro Inc., Center for Devices and Radiological Health (CDRH), Emergo Group, Food & Drug Administration (FDA), Samsung Electronics Co. Ltd.

News Well, Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/NO27ob

Shimmer's sensors target worker's comp injuries | MassDevice.com On Call

Ireland-based Shimmer partners with Emerge Diagnostics for devices that help monitor and manage worker's compensation injuries.

MASSDEVICE ON CALL — Irish sensor maker Shimmer signed a $13.8 million (€10 million) contract with U.S.-based Emerge Diagnostics to partner on technologies to aid management of worker's compensation injuries.

Shimmer's wearable technology provides real-time biophysical and movement data via wireless sensors placed on various parts of the body to perform "Electrodiagnostic Functional Assessment."

Emerge Diagnostics, Shimmer

News Well, On Call, Diagnostics, mHealth (Mobile Health)

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1nWZlOq

dilluns, 24 de març del 2014

AIM: Medtronic, St. Jude recalls illustrate why PMA modifications don't work

A new editorial in the Annals of Internal Medicine criticizes the premarket approval modification process, through which both Medtronic and St. Jude Medical released high-risk products that were later recalled.

Annals of Internal Medicine, Food & Drug Administration (FDA), Medtronic, St. Jude Medical

News Well, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Recalls, Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1jnXwb8

Invendo Medical raises $28M for single-use colonoscope

Invendo Medical says it raised about $28 million for its Invendoscope single-use colonoscopy system.

Invendo Medical said it raised a $28 million (€20.3 million) funding round for its single-use colonoscopy system led by new backer Xeraya Capital.

Kissing, Germany, and New York-based Invendo said a German Family Office also joined the round, which included existing investors TVM Capital, Wellington Partner, 360° Capital and its founders.

360° Capital, Invendo Medical, TVM Capital, Wellington Partners, Xeraya Capital

News Well, Endoscopic / Arthroscopic, Funding Roundup

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1nUnC7F

Corium poised for $66M IPO for wearable drug-delivery devices

California-based Corium unveils plans for a $66 million initial public offering for its transdermal drug delivery technology.

Drug-delivery devices maker Corium could raise up to $66 million through an initial public offering, the company announced in SEC filings today.

Corium plans to offer 5.5 million shares of common stock for $10-$12 apiece, putting its total offering value at between $55-$66 million. At the middle rate of $11 per share, Corium expects its net proceeds to amount to $53.7 million after expenses.

Corium

News Well, Drug-Device Combinations, Initial Public Offering (IPO), Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1psJDpw

Co-founder's son takes over Imaging Dx Systems following SEC settlement with wife

Imaging Diagnostics Systems CEO Linda Grable, wife of co-founder Richard Grable, abdicates the corner office to Richard Grable Jr. pursuant to a settlement with the SEC.

Imaging Diagnostic Systems, Securities & Exchange Commission (SEC)

Legal News, News Well, Imaging, Personnel, Personnel Moves

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1roJUO1

Former CEO sued by InVivo Therapeutics | Medtech legal news for the week of Mar. 24, 2014

Here's a look at some of the top legal news stories for medical device companies this week.

InVivo Therapeutics sues ex-CEO Reynolds

March 18, 2014 by Brad Perriello

InVivo Therapeutics said it's suing former CEO Frank Reynolds, who stepped down last year citing health reasons, alleging that he ran up $500,000 worth of "personal and/or exorbitant expenses."

Volcano Corp., Alphatec Holdings Inc., Biolase Technology Inc., Centers for Medicare and Medicaid Services (CMS), Deerfield Management, InVivo Therapeutics Corp., Oracle Partners, OrthoTec, St. Jude Medical

Legal News, News Well, Legal Roundup

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/ORckB1

FDA updates medtech fast-track review for rare treatments | MassDevice.com On Call

FDA regulators release a Q&A to clarify how medical device makers may seek Humanitarian Device Exemption for treating rare diseases.

MASSDEVICE ON CALL — U.S. healthcare regulators released new documents in efforts to clarify the FDA's Humanitarian Device Exemption pathway, a less-stringent review process for medical devices that treat rare diseases.

The FDA issued a new draft guidance that would allow devices to bypass some of the required safety and efficacy hurdles if it is intended to treat a population of less than 4,000 patients.

Food & Drug Administration (FDA)

News Well, Humanitarian Device Exemption (HDE), Food & Drug Administration (FDA), Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1rn57If

divendres, 21 de març del 2014

Love at first tweet: A look at medtech's 1st forays into the social network

Some medtech CEOs are on Twitter daily, others' Tweets are few and far between, but each company and its leadership must figure out how to introduce themselves to the Twitter universe.

First impressions can be daunting primarily because they can have a long-lasting influence on a relationship, but what does it mean to make a 1st impression online?

Some of medtech's biggest companies have made themselves Twitter regulators, but each had to start somewhere. Here are some of the industry's 1st tweets:

Boston Scientific, Food & Drug Administration (FDA), Intuitive Surgical Inc., Medtronic, ResMed Inc., Twitter Inc., AdvaMed, GE Healthcare

News Well, mHealth (Mobile Health), Trends

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1nL7UM1

The making of an icon | Dr. Tom Fogarty's obsession with innovation

Medtech icon Dr. Tom Fogarty tells MassDevice.com about his unconventional path from upstart tinkerer in the suburbs of Cincinnati to healthcare celebrity in the heart of Silicon Valley, in Part 1 of a 3-part series.

It's been 50 years since Dr. Tom Fogarty invented the catheter-based treatment for blood clots that's now the standard of care. At 80, it would be a cinch for Fogarty to retire to his California vineyard and bask in the reflected glory of his accomplishments.

Fogarty Institute for Innovation

News Well, MassDevice Q&A, Innovation

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/OI8wCg

Abiomed jumps on Medicare reimbursement news

The Centers for Medicare & Medicaid say they plan to keep the same reimbursement rate for treatment with Abiomed's Impella heart pump, sending ABMD shares up on Wall Street.

Abiomed (NSDQ:ABMD) said today that the Centers for Medicare & Medicaid Services plan to maintain the reimbursement rate for treatment with its Impella heart pump when new rates go into effect this fall.

Centers for Medicare and Medicaid Services (CMS), Abiomed Inc.

News Well, Cardiac Assist Devices, Reimbursement, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1h26rI4

FDA: Medtech recalls up 97% since 2003, but that's a good thing

Recalls of faulty medical devices nearly double from 2003 to 2012, but the FDA says the increase is due to growing awareness of what types of problems merit action.

The annual number of medtech recalls nearly doubled from 2003 to 2012, but FDA regulators are calling the skyrocketing figures a win.

There were 604 total recalls in 2003, compared with 1,190 in 2012. The number of Class I recalls, tied to product defects that the FDA says pose a risk of "serious adverse health consequences or death," increased more than 8-fold, from 7 in 2003 to 57 in 2012.

Food & Drug Administration (FDA)

News Well, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance, Trends

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1h26pjt

Korean regulators waive registration requirements for some mobile medical devices

The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.

By Stewart Eisenhart, Emergo Group

Samsung Electronics Co. Ltd.

News Well, Emerging Markets, mHealth (Mobile Health), Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/OHt2ml

Presbia files for $90M IPO

Presbia, maker of the Flexiview Micro-Lens corneal implant, registers for an initial public offering worth up to $90 million.

Presbia, which makes the Flexiview Micro-Lens corneal implant to treat presbyopia, registered with the SEC for an initial public offering of up to $90 million worth of stock.

The Flexiview Micro-Lens is designed to be inserted into a pocket created in the cornea using a laser. The pocket seals itself, holding the 3mm-diameter lens in the center of the visual axis. The 10-minute procedure is reversible and does not require general anesthesia, according to Presbia's website.

Presbia

News Well, Initial Public Offering (IPO), Optical/Ophthalmic, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1r4SEZs

Google Glass startup gains funding for flagship product | Medtech funding stories for the week of Mar. 17, 2014

Here's a look at some of the top funding stories for medical device companies this week.

Augmedix raises $3.2M for Google Glass for docs

March 19, 2014 by Arezu Sarvestani

Augmedix calls itself the "first and largest Google Glass startup poised to revolutionize healthcare," touting a $3.2 million venture funding round and a move to a larger headquarters in San Francisco.

Zimmer Holdings, Altitude Technologies, Augmedix, Bi02 Medical, Draeger Medical, Google Inc., Oculeve, OnTarget Laboratories, Targeted Technology Fund, Texas Emerging Technology Fund, U.S. Defense Dept.

News Well, Funding Roundup

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1hN4ReX

Tenn. Sen. Alexander decries the medtech tax | MassDevice.com On Call

Sen. Lamar Alexander (R-Tenn.) spends some time with Memphis-area medical device industry stakeholders to hone efforts to repeal the 2.3% device tax.

MASSDEVICE ON CALL — Sen. Lamar Alexander (R-Tenn.) is ramping up his opposition to the medical device tax, spending some time with his medtech stakeholders to renew his call to repeal the tax.

U.S. Senate

News Well, On Call, Lobbying, Medical Device Tax

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1hN4P6V

dijous, 20 de març del 2014

Smiths Medical is off the block after dismal H1 earnings

Smiths Group takes its medical division off of the auction block after the division's H1 earnings drop hard and a multi-billion-dollar acquisition offer from CareFusion falls through.

CareFusion Corp., Smiths Group plc, Smiths Medical

News Well, MassDevice.com Earnings Roundup, 2014, Mergers & Acquisitions

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1jd4lba

Playtex recalls breast pump adapters over electrical shock risk

Playtex manufacturing launches a nationwide recall of power adapters shipped with Nurser Deluxe Double Electric Breast Pumps over concerns that they may cause electrical shocks.

Playtex recalls breast pumps over electrical shock risk

FDA regulators issued a memo today warning that certain Playtex breast pumps may have been shipped with faulty power adapters that could cause electrical shocks to users.

The recall affects Playtex Nurser Deluxe Double Electric Breast Pumps with adapters that were manufactured from November 2012 through July 2013. The adapters have casings that may be prone to separation, exposing dangerous components.

Food & Drug Administration (FDA), Playtex

News Well, Food & Drug Administration (FDA), Recalls

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1hIA2rC

K2M Group Holdings looks to raise $100M in IPO | Top Medtech Wall Street stories for the week of Mar. 17, 2014

Here's a look at some of the top Wall Street stories for medical device companies this week.

Spinal firm K2M aims for $100M IPO

March 14, 2014 by Arezu Sarvestani

Spinal surgery devices maker K2M Group Holdings hopes to raise as much as $100 million through its impending initial public offering, according to registration documents filed with the SEC.

Biolase Technology Inc., ConMed Corp., Coppersmith Capital Management, K2M, Oracle Partners, Voce Capital Management

News Well, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1fKmsSh