onmedic news: de gener 2015

divendres, 30 de gener del 2015

Listening to patients' views on new treatments for obesity

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.

Kathryn O’Callaghan, Associate Director for Science and Strategic Partnerships (Acting), FDA's Center for Devices and Radiological Health

By Kathryn O’Callaghan and Jeffrey Shuren, M.D., J.D.

The world was a very different place in 1976, when the Food and Drug Administration launched its medical device program.

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/1tGXHUs

U.S. government releases draft plan for electronic health data

Obama administration proposes a plan to move most doctors, hospitals and their patients to national standards for handling electronic clinical data by the end of 2017.

(Reuters) - The Obama administration on Friday proposed a plan to move most doctors, hospitals and their patients to national standards for handling electronic clinical data by the end of 2017.

The U.S. Department of Health and Human Services (HHS), as part of an effort to propel the $2.9 trillion U.S. healthcare system away from a costly fee-for-service system, released a report draft aimed at establishing an inter operable health information technology system that can be accessed by patients and their healthcare providers.

U.S. Department of Health, White House

News Well, Electronic Medical Records

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1642Omr

Medical device tax: What we talk about when we talk about job losses

MassDevice.com takes a look at how the numbers thrown around about job losses from the medical device tax are calculated.

For going on 5 years now, opponents on both sides of the fight over the medical device tax have engaged in a rhetorical war about the number of jobs that will be lost to the levy.

Zoll Medical Corp., Asahi Kasei Corp., Congressional, Medical Device Manufacturers Assn. (MDMA), AdvaMed

News Well, Layoffs, Medical Device Tax

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

IPO Thursday: Avinger, Entellus upsize, Presbia prices under range

A trio of medical device companies priced their IPOs yesterday, with Avinger and Entellus upsizing their offerings and Presbia pricing under range.

It was medtech IPO day on Wall Street yesterday as a trio of medical device companies priced their initial public offerings.

Avinger, Entellus Medical Inc., Presbia

News Well, 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/1CTDk8y

Abbott CEO White unfazed by strong dollar

Abbott Laboratories

News Well, MassDevice.com Earnings Roundup, 2014, Q4, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1wIy9Be

Care pathways and their kin

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine.

By Westby G. Fisher, MD, FACC

News Well, Blog, Healthcare Reform, Hospital Care, Insurance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1Byy3ik

dijous, 29 de gener del 2015

TAVI: Medtronic CoreValve study shows benefits for CABG patients

Patients who've already had coronary artery bypass graft surgery showed a significant mortality benefit with Medtronic's CoreValve replacement heart valve than with open heart surgery, according to a clinical trial.

Edwards Lifesciences, Medtronic

News Well, Clinical Trials, Replacement Heart Valves

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

USGI Medical raises $20m for weight-loss device

USGI Medical says it raised $19.5 million in new debt and equity financing to fuel international commercial plans and U.S. regulatory efforts for its endoscopic weight-loss device.

California's USGI Medical said it raised $19.5 million in new equity and debt financing designed, in part, to back the final stages of the U.S. approval process for an incision-less endoscopic weight-loss procedure known as POSE.

East West Bank, GE Capital, Healthcare Financial Services, USGI Medical

News Well, Bariatrics, Funding Roundup, Venture Capital/Private Equity, Weight loss

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1yaok0y

FDA reports success in expediting approval process

The FDA's Center for Devices & Radiological Health reports significant progress in expediting the U.S. regulatory approval process for medical devices.

The FDA's Center for Devices & Radiological Health last week reported significant progress in speeding up the U.S. regulatory approval process for medical devices.

Food & Drug Administration (FDA)

News Well, Investigational Device Exemption (IDE), Pre-Market Approval (PMA), Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1z8utPk

BioStructures wins FDA clearance for bone graft scaffold

BioStructures wins the FDA's blessing for a next-generation bone graft product.

California startup BioStructures said it won 510(k) clearance from the FDA for its next-generation bone graft product for spinal fusion procedures.

BioStructures, Food & Drug Administration (FDA)

News Well, 510(k), Orthopedics, Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1Es7z8q

Asante Solutions sets terms for pending IPO | Medtech Wall Street news for the week of January 26, 2015

Here's a look at some of the top Wall Street stories for medical device companies this week: Asante Solutions sets IPO terms; Stryker CEO Lobo: M&A is our top priority for cash; Abiomed surges on Q3 numbers, FDA nod; Credit agencies lower Medtronic's rating post-Covidien merger

Diabetes: Asante Solutions sets IPO terms

January 23, 2015 by Brad Perriello

Asante Solutions, Covidien, Fitch Ratings, Medtronic, Moody's Investor Service, Standard & Poor's, Stryker, 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/1v9tKxs

InspireMD touts new data, CE Mark for CGuard carotid stent

InspireMD reports positive clinical data for its new CGuard MicroNet carotid stent system and CE Mark approval in the European Union for a delivery system that pairs with the product.

InspireMD

News Well, Clinical Trials, CE Mark, Regulatory/Compliance, Stents

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1yDA1vI

Philips, Teva launch Israeli medtech incubator

Sanara Ventures, a medical device and drug development incubator run by Philips Healthcare and Teva Pharmaceuticals, launches operations in Israel.

Royal Philips, Teva Pharmaceuticals

News Well, Drug-Device Combinations

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/18yiFeU

Former Medtronic worker sues company, police over arrest in bomb threat hoax

A former Medtronic worker sues the company and police in Brooklyn Park, Minn., alleging false arrest and imprisonment after he was taken into custody as a suspect in a pair of hoax bomb threats made against the medical device company 2 years ago.

Medtronic

Legal News, News Well

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/15XGmwm

dimecres, 28 de gener del 2015

Credit agencies lower Medtronic's rating post-Covidien merger

Credit agencies Standard & Poor's and Moody's lowered their ratings as promised on Medtronic after it took out a massive debt package to finance its $50 billion acquisition of Covidien.

Covidien, Fitch Ratings, Medtronic, Moody's Investor Service, Standard & Poor's

News Well, Medtronic buys Covidien, Mergers & Acquisitions, Wall Street Beat

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

FDA to require PMAs for automated external defibrillators

The FDA says it will require automated external defibrillators to undergo its strict pre-market approval process.

Zoll Medical Corp., Food & Drug Administration (FDA), Physio-Control Inc., Royal Philips

News Well, Cardiac Rhythm Management, Pre-Market Approval (PMA), Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1BpT0vK

Medtech execs: We'll step up hiring if the medical device tax is repealed

Medical device executives surveyed by the Medical Device Manufacturers Assn. say they'll step up hiring if the medical device tax is repealed.

Repealing the job-killing medical device tax will serve as job creator, a survey of medical device executives revealed today.

Volcano Corp., Zoll Medical Corp., Medical Device Manufacturers Assn. (MDMA)

News Well, Capitol Hill, Medical Device Tax

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1K4O4RS

Abiomed surges on Q3 numbers, FDA nod

Abiomed shares surge to an all-time high after the heart pump maker crushes expectations with its fiscal 3rd-quarter results and raises its outlook for the rest of fiscal 2015.

Abiomed (NSDQ:ABMD) shares surged to an all-time high today after the heart pump maker crushed expectations for its fiscal 3rd quarter and raised its outlook on the rest of the year.

Abiomed Inc.

News Well, MassDevice.com Earnings Roundup, 2014, Cardiac Assist Devices, Q4, Wall Street Beat

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

AdvaMed claims 195,000 jobs lost to medical device tax

AdvaMed claims that the medical device tax will wind up costing the U.S. economy 195,000 jobs, citing a survey of 55 of its medical device company members.

The national medical device industry lobby today claimed that the medical device tax enacted as part of Obamacare will wind up costing the U.S. economy 195,000 jobs and hamstring medtech firms' R&D efforts.

AdvaMed

News Well, Medical Device Tax

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

St. Jude Medical's Q4, 2014 profits surge

St. Jude Medical's 4th-quarter and 2014 profits surge as its sales and earnings meet expectations on Wall Street.

St. Jude Medical

News Well, MassDevice.com Earnings Roundup, 2014, Cardiac Rhythm Management, Q4

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

dimarts, 27 de gener del 2015

Congressional panel wants priority review program for medtech

21st Century Cures, a bipartisan panel led by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.), calls for the FDA to create a new, expedited review process for medical technology designed to address unmet needs.

A congressional panel is calling fora new, expedited priority review process for medical technology aimed at unmet medical needs, similar to similar programs for drugs and biologics.

Food & Drug Administration (FDA), U.S. House of Representatives

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

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

FDA approves St. Jude Medical's FlexAbility catheter

The FDA approves St. Jude Medical's FlexAbility ablation catheter for treating cardiac fibrillation.

Food & Drug Administration (FDA), St. Jude Medical

News Well, Cardiac Rhythm Management, Catheters, Pre-Market Approval (PMA), Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1z0qYKH

Stryker's Q4, 2014 profits slump on recall costs

Stryker reports slumping profits for the 4th quarter and all of 2014, blaming in part the recalls of its Rejuvenate and ABG II hip implants and Neptune waste management device.

Stryker (NYSE:SYK) today reported slumping profits for the 4th quarter and all of 2014, missing earnings expectations by a penny after the cost of several recalls suppressed the bottom line.

Stryker

News Well, MassDevice.com Earnings Roundup, 2014, Orthopedics, Q4

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

FDA approves Abiomed's Impella RP

Abiomed wins a humanitarian device exemption for its Impella RP

Abiomed (NSDQ:ABMD) today said the FDA approved a humanitarian device exemption for its Impella RP heart pump, calling the device the 1st FDA-approved percutaneous, single-access pump for supporting the heart's right ventricle.

Food & Drug Administration (FDA), Abiomed Inc.

News Well, Humanitarian Device Exemption (HDE), Cardiac Assist Devices

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1zsEJ6w

Philips' Q4 profits plunge on Cleveland plant closing

The closure of a Cleveland plant that makes CT scanners pushed Royal Philips' overall profits down and slashed its Philips Healthcare division's bottom line by nearly 28%.

Royal Philips

News Well, MassDevice.com Earnings Roundup, 2014, Imaging, Q4

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

MDT wins HDE for Enterra II | Regulatory news for the week of January 26, 2015

Here's a look at some of the top regulatory stories for medical device companies this week: Medtronic wins HDE for Enterra II neurostim device; FDA officially clears Integra's Puerto Rico plant; Nevro surges on Senza approvable letter from FDA; mHealth: AliveCor wins CE Mark for new afib algorithm; FDA warns against pediatric use of bone growth proteins

Medtronic wins HDE for Enterra II neurostim device

January 23, 2015 by Brad Perriello

AliveCor, Food & Drug Administration (FDA), Integra LifeSciences Corp., Medtronic, Nevro Corp., Stryker

News Well, Regulatory/Compliance

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

With Q1 healthcare profits down 13%, Siemens shakes up management

With fiscal 1st-quarter profits down nearly 13% at Siemens Healthcare, the German conglomerate shakes things up with a new management team.

Siemens

News Well, MassDevice.com Earnings Roundup, 2014, Personnel, Q4

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

Medtronic buyout complete, Covidien closes Stellarex deal with Spectranetics

Covidien and Spectranetics close the $30 million deal for the Stellarex drug-eluting balloon, following the close yesterday of Medtronic's $50 billion acquisition of Covidien.

Covidien, Medtronic, Spectranetics Corp.

News Well, Medtronic buys Covidien, Mergers & Acquisitions, Peripheral Artery Disease

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

Medtech slams gov't report on medical device tax

Medical device executives and Rep. Erik Paulsen (R-Minn.) scoff at a government report saying the levy's impact will be limited, telling MassDevice.com they're more confident than ever about repealing the medical device tax.

Medtech executives last week bashed a newly updated report from the Congressional Research Service refuting claims that the medical device tax kills jobs and hampers innovation.

Zoll Medical Corp., Masimo, U.S. Congress

News Well, Capitol Hill, Medical Device Tax

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1Burq2Y

Live imaging captures how blood stem cells take root in the body

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, Big Data, Blog

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/15OCrBR

dilluns, 26 de gener del 2015

FDA names cardiologist Califf to senior leadership position

The FDA names cardiologist and researcher Dr. Robert Califf of Duke University to be deputy commissioner for medical products & tobacco.

FDA names cardiologist to senior leadership position

(Reuters) — The FDA today named Dr. Robert Califf, a cardiologist and researcher, to oversee its drug, medical device and tobacco policy, in what experts said is a coup for the FDA.

Duke University, Food & Drug Administration (FDA)

News Well, Personnel

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1H1oroB

Supremes send patent cases back to appeals court

The U.S. Supreme Court remands a trio of patent cases back to a lower court for further proceedings in light of a ruling the justices issued last week.

U.S. Supreme Court

Legal News, News Well, Patent Infringement

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/18lzHwP

Medtech approvals: FDA releases November 2014 PMAs

The U.S. Food & Drug Administration releases a list of pre-market approvals granted in November 2014.

Summary of PMA Originals & Supplements Approved

Originals: 2

Supplements: 67

Summary of PMA Originals Under Review

Total Under Review: 55

Total Active: 26

Total On Hold: 29

Sign up to get our free newsletters delivered straight to your inbox

Summary of PMA Supplements Under Review

Food & Drug Administration (FDA)

News Well, Pre-Market Approval (PMA), Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1Jv415k

U.S. wants to move Medicare away from fee-for-service

The Obama administration wants to change the way Medicare reimburses doctors, moving from a fee-for-service model to alternative payment models emphasizing cost containment and quality of care.

(Reuters) — The Obama administration today unveiled an ambitious plan to control health costs by moving the $2.9 trillion U.S. healthcare systems away from costly fee-for-service medicine, beginning with the Medicare program for the elderly and disabled.

Centers for Medicare and Medicaid Services (CMS), Dept. of Health & Human Services (HHS)

News Well, Healthcare Reform

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1Jv43tY

Rox Medical's Coupler hypertension stent fares well in pivotal trial

Rox Medical's stent-like Coupler implant, designed to treat resistant hypertension, fares well in a pivotal trial.

A stent-like device designed to treat high blood pressure fared well in a pivotal trial comparing it with treatment with drugs alone.

Rox Medical

News Well, Clinical Trials, Hypertension

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

Accused killer of Boston Scientific executive pleads guilty

Lyle 'Ty' Hoffman reportedly pleads guilty to intentional 2nd-degree murder in the shooting death of former Boston Scientific executive Kelly Phillips.

Hoffman (l) and Phillips

Boston Scientific

Legal News, News Well

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

Diabetes: FDA clears DexCom's mobile apps

The FDA clears DexCom's Share and Follow apps for diabetes patients using the company's G4 Platinum continuous glucose monitor, allowing patients and caregivers to track glucose levels on up to 5 mobile devices.

Dexcom Inc. (NSDQ:DXCM) won de novo approval from the FDA for the 1st U.S. app to wirelessly connect a patient's blood glucose monitor with up to 5 mobile devices.

DexCom Inc., Food & Drug Administration (FDA), Google Inc., Apple

News Well, De Novo Clearance, Diabetes, mHealth (Mobile Health), Regulatory/Compliance

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

Maquet inks marketing deals with ClearFlow, InterValve

Maquet Medical inks exclusive U.S. marketing deals for ClearFlow's PleuraFlow chest-drainage system and InterValve's V8 balloon catheter.

ClearFlow (formerly Clear Catheter Systems), Getinge Group, InterValve Inc., Maquet Cardiovascular LLC

News Well, Cardiovascular, Distribution

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1tguAY2

JNJ settles more Mentor mesh cases | Medtech legal news for the week of January 26, 2015

Here's a look at some of the top legal news stories for medical device companies this week: Johnson & Johnson settles another batch of Mentor pelvic mesh cases; J&J's $7B claim against Boston Scientific goes to the judge; Arthrex loses appeal of $33m loss to KFx

Johnson & Johnson settles another batch of Mentor pelvic mesh cases

January 21, 2015 by Brad Perriello

Arthrex Inc., Boston Scientific, Guidant Corp., Johnson & Johnson, KFx Medical, Mentor Corp., Abbott Laboratories

Legal News, News Well, Legal Roundup

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

ANVISA granted more leverage to prioritize medical device-related health risks

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

A new Brazilian law allows ANVISA, the country's medical device market regulator, greater latitude to manage public health risks and surveillance measures in a way that may also boost efficiencies for Brazilian market registrants.

Emergo Group

News Well, Emerging Markets, Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1zNMe7N

FLASH: Irish High Court OKs Medtronic's $43B Covidien buy

The largest merger in medtech history is expected to close later today after the Irish High Court sanctions the $43 billion union of Medtronic and Covidien.

Covidien, Irish High Court, Medtronic

News Well, Medtronic buys Covidien, Mergers & Acquisitions

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/15KxyK9

Med-El wins FDA approval for Synchrony MRI-safe cochlear implant

Med-El wins pre-market approval from the FDA for its Synchrony MRI-safe cochlear implant.

Med-El wins FDA approval for MRI-safe cochlear implant

Med-El USA said it plans to start selling its Synchrony MRI-safe cochlear implant in the spring of 2015, following the FDA's decision to sign off on the novel device.

Food & Drug Administration (FDA), Med-El USA

News Well, Hearing, Imaging, Pre-Market Approval (PMA)

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/15Kxwlj

divendres, 23 de gener del 2015

Russian regulators publish new medical device nomenclature system

By Stewart Eisenhart, Emergo Group

Roszdravnadzor, Russia's medical device market regulator, has published a new system for nomenclature classification according to 19 different device types.

Emergo Group

News Well, Emerging Markets, Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1EbBG3W

Ekso Bionics expands role in military 'supersuit' project

Ekso Bionics expands its role in a U.S. military project aimed at building an exoskeleton with 'superhuman' capabilities.

Ekso Bionics

News Well, Robotics, Military, Prosthetics

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1BShHX6

Ex-Insulet CFO Roberts lands at Avedro | Personnel Moves

Avedro taps ex-Insulet CFO Brian Roberts to be its new finance chief, replacing Rhonda Bracey, who is relocating to the West Coast.

Zimmer Holdings, ACell, AtriCure Inc., Avedro Inc., Avinger, Check-Cap, Covidien, Given Imaging, Hologic Inc., Insulet Corp., Invacare Corp., Nextremity Solutions, OCTANe, OrthoPediatrics Corp., Repro-Med Systems Inc.

News Well, Personnel Moves

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1xKK2Iq

Nevro surges on Senza approvable letter from FDA

Nevro shares surge on news of its receipt of an 'approvable letter' from the FDA for its Senza spinal cord stimulator for chronic pain.

Food & Drug Administration (FDA), Nevro Corp.

News Well, Neuromodulation/Neurostimulation, Pain Management, Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1AYWWn6

Medtech approvals: FDA releases October 2014 PMAs

The U.S. Food & Drug Administration releases a list of pre-market approvals granted in October 2014

Summary of PMA Originals & Supplements Approved

Originals: 2

Supplements: 87

Summary of PMA Originals Under Review

Total Under Review: 54

Total Active: 24

Total On Hold: 30

Summary of PMA Supplements Under Review

Food & Drug Administration (FDA)

News Well, Pre-Market Approval (PMA), Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1CZ02de

GE Healthcare's Q4 profits slide on flat sales growth

Profits for General Electric's GE Healthcare business were down 4% on flat sales during the 4th quarter.

GE Healthcare

News Well, MassDevice.com Earnings Roundup, 2014, Q4

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1xJcH0z

Hansen Medical touts 1st robotic IVC filter retrieval

Hansen Medical touts the use of its Magellan robotic system in the world's 1st robot-assisted retrieval of an inferior vena cava filter.

Hansen Medical Inc.

News Well, Robot-Assisted Surgery

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

mHealth: AliveCor wins CE Mark for new afib algorithm

AliveCor, with CE Mark in hand, will roll out an updated app in the United Kingdom and Ireland that detects atrial fibrillation.

AliveCor said it plans to launch the latest version of its app to detect atrial fibrillation in the U.K. and Ireland after winning CE Mark approval in the European Union for the updated tech.

AliveCor

News Well, Cardiac Rhythm Management, CE Mark, mHealth (Mobile Health), Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/15wYdcq

Medical device panel outlines pathways to market

By Erin Horan

Physicians often dream of creating new devices to help their patients, but few are able to bring a device to market. At a panel discussion earlier this month at Boston Children's Hospital, an entrepreneur, a venture capitalist and medical device industry experts offered advice for inventors who want to make their medical device a commercial reality. Here's some of what they had to say.

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/1CslbP1

VCs put more into medtech last year | Medtech funding for the week of January 19, 2015

Here's a look at some of the top legal news stories for medical device companies this week: VCs put more into fewer medtech deals last year; Samsung leads $20m round for EarlySense; K2M registers for $40m follow-on

Report: VCs put more into fewer medtech deals last year

January 20, 2015 by Brad Perriello

EarlySense, Food & Drug Administration (FDA), K2M, National Venture Capital Assn. (NVCA), PricewaterhouseCoopers (PwC), Samsung Electronics Co. Ltd., Thomson Reuters

News Well, Funding Roundup

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1CYpZd7

dijous, 22 de gener del 2015

Intuitive Surgical dips after hours on Q4 results

Intuitive Surgical shares dip in after-hours trading as investors react to 4th-quarter results showing rising expenses, sliding profits and poor year-on-year comps.

Intuitive Surgical Inc.

News Well, MassDevice.com Earnings Roundup, 2014, Q4, Robot-Assisted Surgery

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