onmedic news: 2014

dimecres, 31 de desembre del 2014

Quality assurance for genome editing

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.

When chromosomes break, the ends can join together in a number of ways, some of which can cause trouble. A new QA method could help researchers avoid making problematic breaks when using gene editing technologies like CRISPR.

By Tom Ulrich

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://www.massdevice.com/blogs/massdevice/quality-assurance-genome-editing

dimarts, 30 de desembre del 2014

Ex-MLB player DeCinces asks federal court to throw out case in Abbott-AMO insider trading flap

Ex-Orioles player Doug DeCinces said a Second Circuit decision offers reason to throw out insider trading charges against him involving ex-Advanced Medical Optics CEO James Mazzo.

Feds fight dismissal of charges in Abbott-AMO insider trading case

Doug DeCinces, the ex-professional baseball player for the Baltimore Orioles, embroiled in an insider trading case linked to the former CEO of Advanced Medical Optics, is using a newly decided appeals case in an attempt to get charges against him thrown out of court.

Abbott Medical Optics

Legal News, News Well

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/news/ex-mlb-player-decinces-asks-federal-court-throw-out-case-abbott-amo-insider-trading-flap

Another important step in FDA's journey towards enhanced safety through full-scale "active surveillance"

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 Janet Woodcock, M.D.

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://www.massdevice.com/blogs/massdevice/another-important-step-fdas-journey-towards-enhanced-safety-through-full-scale-acti

Report: BiOM may file for IPO in 2016

Personal bionics maker BiOM may take its case to the public markets, eyeing a potential initial public offering, according to a report in the Boston Business Journal.

Exclusive: Bionics maker BiOM taps Charles Carignan for CEO role

Personal bionics maker BiOM may eventually take its case to the public markets, eyeing a potential initial public offering, according to a report in the Boston Business Journal.

BiOM, General Catalyst, NinePoint Medical Inc., Second Sight Medical Products Inc.

News Well, Initial Public Offering (IPO), Prosthetics

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/news/report-biom-may-file-ipo-2016

Elder-care challenges prompt tech execs to create startups, apps

A growing number of high-level Silicon Valley executives from the "sandwich generation" - those who are simultaneously caring for children and parents - have left their jobs to launch mobile and digital health startups

Facebook, Google Inc.

News Well, Digital Health

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/news/elder-care-challenges-prompt-tech-execs-create-startups-apps

Medical Device Tax: Rep. Charlie Dent puts repeal at top of GOPs priority list for 2015

Pennsylvania Republican Charlie Dent, who will serve as chairman of the House Ethics Committee in the next Congress, says GOP should focus on repealing the medical device tax immediately.

Rep. Charlie Dent (R-Pa.) says repealing the 2.3% medical device excise tax should be 1 of the GOP's top priorities after it assumes control of both houses of Congress next month.

Capitol Hill

News Well, Capitol Hill, Medical Device Tax

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/news/medical-device-tax-rep-charlie-dent-puts-repeal-top-gops-priority-list-2015

Chinese regulators agree to accelerated market access for US 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

Chinese government officials have agreed to reduce registration timelines for US medical device manufacturers during bilateral trade talks in Chicago.

Emergo Group

News Well, Emerging Markets, Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/blogs/massdevice/chinese-regulators-agree-accelerated-market-access-us-medical-devices

dilluns, 29 de desembre del 2014

Entellus Medical registers for $69m IPO

Entellus Medical, maker of devices to treat clogged sinuses, released plans for a proposed IPO worth as much as $69 million.

Minnesota's Entellus Medical disclosed a proposed initial public offering shortly before Christmas, with plans to raise as much as $69 million.

No date for the offering has been set as of yet. Plans are to trade on the NASDAQ exchange under the symbol "ENTL," according to a regulatory filing.

Entellus Medical Inc.

News Well, Initial Public Offering (IPO), Otolaryngology/Ear, Nose & Throat (ENT)

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/news/entellus-medical-registers-69m-ipo

Seizure-detecting wristband could prevent sudden death from epilepsy

By Nancy Fliesler

"My biggest fear is that if I am not there to help him, when I wake him up he will be dead from seizures."

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://www.massdevice.com/blogs/massdevice/seizure-detecting-wristband-could-prevent-sudden-death-epilepsy

ITC issues final ruling in ResMed spat with BMC Medical

The International Trade Commission issues a mixed final decision in a patent infringement war over sleep apnea devices between ResMed and China's BMC Medical.

BMC Medical, ResMed Inc.

Legal News, News Well, Patent Infringement

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/news/itc-issues-final-ruling-resmed-spat-with-bmc-medical

Covidien inks deal to settle lawsuit over Medtronic merger

Covidien agrees to a deal that would settle a consolidated derivatives lawsuit filed by shareholders looking to block its $43 billion merger with Medtronic.

Covidien, Medtronic

Legal News, News Well, Medtronic buys Covidien, Mergers & Acquisitions

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/news/covidien-inks-deal-settle-lawsuit-over-medtronic-merger

India eases foreign ownership rules for medical device makers

India eases restrictions on foreign ownership of companies in its $7 billion medical device industry.

(Reuters) — India has made it easier for foreigners to fully own existing medical device makers in the country, in a bid to boost investment in the $7 billion sector.

The government said Dec. 24 that foreigners wanting to buy 100% of device makers no longer need to get prior approval.

News Well, Exports, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/news/india-eases-foreign-ownership-rules-medical-device-makers

Judge won't stop Medtronic plan to cover $63m tax tab for execs, directors

A Minnesota federal judge declines to stop Medtronic's plan to cover a $63 million tax tab stemming from its Covidien buyout for its top executives and directors.

Covidien, Medtronic

Legal News, News Well, Medtronic buys Covidien, Mergers & Acquisitions, Personnel

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/news/judge-wont-stop-medtronic-plan-cover-63m-tax-tab-execs-directors

dimarts, 23 de desembre del 2014

Prosthetic arm reads muscle impulses

A prosthetic arm developed in Argentina uses sensors to respond to nerve impulses.

REUTERS/Enrique Marcarian. Click image to enlarge

Bioparx Health Technology

News Well, Prosthetics

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

Ekso raises $23m, needs 510(k)

Robotic exoskeleton maker Ekso Bionics pulls in nearly $23 million, but must pursue 510(k) clearance from the FDA for its main product.

Ekso Bionics, Food & Drug Administration (FDA)

News Well, Robotics, 510(k), Funding Roundup, Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1A0MRcA

Year in review: CEOs chime in on 2014

MassDevice.com asks medical device CEOs about the key issues of 2014 and what's ahead for the New Year.

As 2014 draws to a close, MassDevice.com asked several medical device company CEOs for their takes on 2014 and what they're looking for in 2015.

We wanted to get their views on the major trends seen in medtech this year, including the red-hot M&A and IPO scenes, the medical device tax, the regulatory environment in the U.S., and more.

Arch Therapeutics, Edwards Lifesciences, Haemonetics, MassDevice.com, Neurometrix, OMNIlife Science Inc., Alliqua Biomedical

News Well

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1B2bHXv

FDA awards priority review status to Cohera Medical's surgical sealant Sylys | Regulatory news for the week of December 22, 2014

Here's a look at some of the top regulatory stories for medical device companies this week: Cohera's Sylys sealant wins quick review at FDA; Hypertension: CVRx wins FDA nod for Barostim neo legacy; Sorin wins FDA nod for Memo3d ReChord mitral annuloplasty ring; Bio2 Technologies wins FDA nod for bioactive bone scaffolds; FDA approves Cerus blood plasma purification device

Cohera's Sylys sealant wins quick review at FDA

December 18, 2014 by Val Kennedy

Bio2 Technologies, Cerus Corp., Cohera Medical Inc., CVRx Inc., Food & Drug Administration (FDA), Sorin Group

News Well, Regulatory/Compliance

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1CC9wvc

BeneChill files for $14m IPO

BeneChill registers for an initial public offering worth $14 million for RhinoChill brain-cooling device.

The red-hot IPO market for medical device companies shows no signs of abating as the year comes to a close, with BeneChill yesterday tossing its hat in the ring for a nearly $14 million flotation.

BeneChill Inc.

News Well, Cryogenics, Initial Public Offering (IPO)

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1B1SwNB

Abbott closes $250m Topera buyout

Abbott says it closed the $250 million buyout of Topera Medical and its cardiac arrhythmia mapping technology.

Abbott (NYSE:ABT) said yesterday that it closed its acquisition of Topera Medical, paying $250 million up front and placing another unspecified amount on the table in performance-based milestones.

Topera Medical, Abbott Laboratories

News Well, Cardiac Rhythm Management, Mergers & Acquisitions

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1xHNCb1

Infraredx files for $55m IPO

Intravascular imaging company Infraredx files for an initial public offering worth $55 million.

Infraredx yesterday registered for an initial public offering with the Securities & Exchange Commission, estimating the flotation's worth at $55 million.

Burlington, Mass.-based Infraredx makes an imaging system that combines intravascular ultrasound and near-infrared spectroscopy to provide images of the interior of coronary blood vessels.

InfraReDx Inc.

News Well, Imaging, Initial Public Offering (IPO), Vascular

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

FDA approves Eos Imaging's 3D orthopedic software

The FDA approves Eos Imaging's hipEos 3D software for planning hip replacement surgeries.

Eos Imaging said the FDA approved its hipEos 3D software for planning hip replacement surgery.

Eos said the software uses patients' anatomical data to create a functional, weight-bearing 3D image that can help physicians determine what size implant to use and how it should be positioned.

Eos Imaging, Food & Drug Administration (FDA)

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

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

Study: Medtronic's In.Pact Admiral balloon beats standard angioplasty

Medtronic touts a new study showing that its In.Pact Admiral drug-eluting balloon performed better than a standard angioplasty balloon in the treatment of symptomatic peripheral artery disease of the upper leg.

Medtronic, American Heart Assn.

News Well, Clinical Trials, Peripheral Artery Disease

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1ADu4Ef

Seeding medical innovation: The Technology Development Fund

By Monique Yoakim

Since 2009, Boston Children's Hospital has committed $6.2 million to support 58 hospital innovations ranging from therapeutics, diagnostics, medical devices and vaccines to regenerative medicine and healthcare IT projects. What a difference six years makes.

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/1GThK4K

dilluns, 22 de desembre del 2014

Zoll Medical to acquire Advanced Circulatory Systems

Zoll Medical agrees to acquire Advanced Circulatory Systems and its noninvasive circulatory support devices for an unspecified amount.

Zoll Medical is averaging an acquisition per month over the fall, announcing its 3rd deal in as many months, this time for Advanced Circulatory Systems and its non-invasive circulation assist devices.

Zoll Medical Corp., Advanced Circulatory Systems Inc.

News Well, Mergers & Acquisitions

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1x3XwAZ

Iradimed gets MRI infusion pump back on the market

Iradimed's stock shoots up nearly 15% on news that it can return to market with MRI-friendly intravenous infusion pump systems, which were pulled after an FDA inspection.

Food & Drug Administration (FDA), Iradimed Corp

News Well, 510(k), Drug Pumps, Imaging, Regulatory/Compliance, Warning Letter

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1JJ8HWo

2014 in review: Changes at the top for medical device companies

There was a significant amount of turnover this year in the corner offices of medical device companies, including exits by some of medtech's biggest names.

There was a revolving door on medtech's corner office this year, with more than 35 CEOs leaving their positions through planned transitions, retirement or termination, according to a MassDevice.com analysis.

ConMed Corp., Covidien, Insulet Corp., Philips Healthcare, Travis & Co., Allergan Inc., GI Dynamics

News Well, Personnel, Personnel Moves

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1t1vQOG

NxStage Medical wins FDA nod for nocturnal home dialysis

NxStage Medical says it won 510(k) clearance from the FDA for nocturnal home hemodialysis treatments using its System One device.

Food & Drug Administration (FDA), NxStage Medical Inc.

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

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1zbM9Fa

Diabetes: Asante Solutions registers for $45m IPO

Modular insulin pump maker Asante Solutions files for a $45 million initial public offering.

Asante Solutions registered for a $45 million initial public offering for its modular Snap insulin pump, which is designed to use pre-loaded insulin cartridges.

Asante Solutions

News Well, Diabetes, 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/1wVYTTq

divendres, 19 de desembre del 2014

Meridian Medical Technologies lands $130m Pentagon deal for nerve agent antidotes

The U.S. Defense Dept. agrees to pay Meridian Medical Technologies $130 million to develop auto-injectors that can deliver nerve agent antidotes.

Maryland's Meridian Medical Technologies is moving ahead with a whopping $129.5 million U.S. government contract to develop auto-injectors that can deliver nerve agent antidotes.

Meridian Medical Technologies, U.S. Defense Dept.

News Well

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1Cahb6E

Bio2 Technologies wins FDA nod for bioactive bone scaffolds

The FDA grants 510(k) clearance for Bio2 Technologies' CLM bioactive scaffold wedges.

Massachusetts startup Bio2 Technologies plans a limited rollout in 2015 of its high-tech bioactive bone scaffold wedges, following the FDA's recent 510(k) clearance of the product.

Bio2 Technologies, Food & Drug Administration (FDA)

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

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1Ce3AIK

Medicare drops national coverage decisions for some lobotomies, tinnitus masking, others

The Centers for Medicare & Medicaid Services will officially remove national coverage decisions for 7 procedures under a program initiated in November 2013, including stereotactic cingulotomy, tinnitus masking and more.

The Centers for Medicare & Medicaid Services are removing national coverage decisions for 7 medical procedures, including certain types of lobotomies and tinnitus masking devices, after a year-long review initiated in November 2013.

Centers for Medicare and Medicaid Services (CMS)

News Well, Reimbursement

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1Ce3DEc

Appeals court overturns triple damages in Stryker-Zimmer spat

Zimmer is off the hook for the triple damages it owed Stryker after a patent infringement loss last year.

Zimmer Holdings, Stryker Corp.

Legal News, News Well, Patent Infringement, Surgical

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1z44h3G

Report: FDA grounds plan to test unmanned inspection drones

The FDA reportedly grounds an internal feasibility study of using unmanned drones in facility inspections.

An FDA proposal to test unmanned drones in facility inspections was grounded before it could take flight, according to a report in Regulatory Focus.

An internal FDA memo obtained by the publication revealed that the agency was planning to "perform a test of drone technology" sometime this week.

Food & Drug Administration (FDA)

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

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1zcM49m

Pulmonx taps ex-Asthmatx CEO French for the corner office | Personnel Moves

Pulmonx taps former Asthmatx CEO Glen French to be its new chief executive.

Pulmonx said yesterday that it named Glen French, the co-founder and CEO of Asthmatx who led it to an acquisition by BSX, to be its new president and chief executive.

Zimmer Holdings, Aloka Co., Asthmatx Inc., Becton Dickinson & Co., Boston Scientific, Mayo Clinic, Milestone Scientific Inc., NxStage Medical Inc., Pulmonx, Quest Diagnostics Inc., ResMed Inc., ReWalk Robotics, RTI Surgical, AdvaMed

News Well, Personnel Moves

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1v8rtfX

InSightec names Ferré for board, raises $59m for ExAblate fibroid device | Medtech funding for the week of December 15, 2014

Here's a look at some of the top legal news stories for medical device companies this week: InSightec raises $59m, taps ex-Mako CEO Ferré for board; Engineer looks to crowdfund heart valve; Aethlon sells $3.3m in securities to investment fund; Stealthy Cotera raises nearly $8m for knee implants

InSightec raises $59m, taps ex-Mako CEO Ferré for board

December 15, 2014 by Brad Perriello

Aethlon Medical Inc., Cotera, InSightec Ltd, Savant Holdings, The Foundry

News Well, Funding Roundup

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

China to cut red tape on imports of medical devices, medicine

The U.S. says it hammered out a deal with China to speed American-made medical devices and drugs to the Chinese market.

(Reuters) — China agreed to allow U.S. medical devices and medicines into local markets more quickly and open up its anti-trust procedures, U.S. Commerce Secretary Penny Pritzker said yesterday after bilateral trade talks between the 2 nations.

U.S. Commerce Dept.

News Well, Exports, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1zH4Y7h

dijous, 18 de desembre del 2014

Cohera's Sylys sealant wins quick review at FDA

The FDA awards priority review status to Cohera Medical's surgical sealant Sylys because the product addresses a significant unmet medical need.

The FDA awarded priority review status to Cohera Medical's surgical sealant Sylys because the product addresses a significant unmet medical need.

Cohera Medical Inc., Food & Drug Administration (FDA)

News Well, Regulatory/Compliance, Surgical

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1wQR6oD

Sonoma Orthopedic raises $12 million for ankle implant

Sonoma Orthopedic Products raises $12 million from First Analysis for its 'flexible-to-rigid' ankle implants.

Sonoma Orthopedic Products added $12 million to its coffers, thanks to private equity shop First Analysis, saying it plans to use the proceeds to get its "flexible-to rigid" ankle implant on the U.S. market.

Sonoma Orthopedic Products

News Well, Extremities, Funding Roundup, Orthopedics

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

AliveCor plans January debut on Amazon for 3rd-gen home heart monitor

AliveCor said it will start selling its 3rd-generation at-home heart monitor on Amazon.com in January, with help from Japanese medtech titan Omron Healthcare.

AliveCor is rolling out a 3rd-generation version of its at-home heart monitor, with plans to put the device on the market at Amazon.com next month.

AliveCor, Amazon, Omron

News Well, Home Healthcare, Remote Patient Monitoring

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

FDA OKs expedited enrollment for InVivo study

The FDA approves an expedited enrollment plan for a 5-patient pivotal study testing InVivo Therapeutics' neuro-spinal scaffold devices in the treatment of severe spinal cord injuries.

Food & Drug Administration (FDA), InVivo Therapeutics Corp.

News Well, Clinical Trials, Regenerative Medicine, Spinal

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1AkjEt7

Medtronic CEO Omar Ishrak on Covidien deal, value based healthcare at LSA2014

Medtronic CEO Omar Ishrak speaks with Lifescience Alley CEO Shaye Mandle at LSA2014.

LifeScience Alley, Medtronic

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

Stealthy Cotera raises nearly $8m for knee implants

Stealthy knee implant startup Cotera reports raising more than $7.8 million in an equity offering.

Stealthy Cotera, a developer of implantable devices to treat knee osteoarthritis, lifted the veil enough to report raising more than $7.8 million in an ongoing equity offering.

Cotera, The Foundry

News Well, Funding Roundup, Orthopedics

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1GV9tLJ

Aethlon sells $3.3m in securities to investment fund

Aethlon Medical deals $3.3 million in securities to an unnamed healthcare-focused investment fund, according to a recent regulatory filing and the company.

Aethlon Medical (OTC:AEMD) said it dealt $3.3 million worth of securities an investment fund, as it pursues various approvals for its Hemopurifier blood filtration device.

Aethlon Medical Inc.

News Well, Funding Roundup

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1r32huP

Integra launches regenerative burn treatment

Integra Lifesciences launches its latest skin-regeneration product for 3rd-degree burns and scar contractures that haven't responded to other therapies.

linx

Integra LifeSciences Corp.

News Well, Wound Therapy

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

EU's top court opens door to some stem cell patents

Europe's top court today opened the door to stem cell patents in the European Union, ruling that an organism incapable of developing into a human is not an embryo and may be patented.

(Reuters) — Europe's top court today opened the door to certain stem cell patents in the European Union by ruling that an organism incapable of developing into a human being is not a human embryo and may be patented.

European Patent Office

Legal News, News Well, Stem Cells

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1zzU9Uk

2014: The year of the medtech IPO | Medtech Wall Street news for the week of December 15, 2014

Here's a look at some of the top Wall Street stories for medical device companies this week: Year in review: 2014 was the year of the medtech IPO; Symmetry Medical closes surgical spinout, OEM sale; Inogen affirms 2014 outlook, predicts 2015 growth of up to 25%

Year in review: 2014 was the year of the medtech IPO

December 10, 2014 by MassDevice staff

Volcano Corp., Inogen, Johnson & Johnson, K2M, Medtronic, Nevro Corp., Ocular Therapeutix Inc., Sientra, Symmetry Medical Inc., Symmetry Surgical, Tecomet Inc., TriVascular

News Well, Wall Street Beat

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/13giXUT

FDA warns on 'keepsake' ultrasounds

The FDA warns consumers about the health risks of so-called "keepsake" fetal ultrasound imaging and over-the-counter fetal heartbeat monitors.

The FDA wants to dissuade expecting parents from using unregulated fetal ultrasound devices to create "keepsake" images or monitor their babies' heartbeats at home, warning that the devices pose serious risks in untrained hands.

Food & Drug Administration (FDA)

News Well, Imaging, Obstetrics

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1wlJH1O

Biological 'programmers' crack new code in stem cells

Researchers discovered many small nuances in pluripotency states of stem cells by subjecting the cells to various perturbations and then analyzing each individual cell to observe all the different reactions to developmental cues within a stem cell colony. (Credit: Wyss Institute at Harvard University)

By Kat J. McAlpine

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/1zzo3a5

dimecres, 17 de desembre del 2014

Varian nabs German cancer screening software maker MeVis Medical

Varian Medical Systems says it agreed to pay $37 million to acquire German cancer screening software maker MeVis Medical Solutions.

MeVis Medical Solutions, Varian Medical Systems

News Well, Imaging, Mergers & Acquisitions, Software / IT

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/13bSO9I

Indian authorities scrutinizing medical device pricing practices

By Stewart Eisenhart, Emergo Group

The Indian government has begun requesting pricing data from medical device and pharmaceutical product manufacturers in order to more tightly monitor extreme, potentially illegal price variations.

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/1Gt6POX

China halts anti-dumping probe into EU, Japan dialysis kit makers

China closes out an anti-dumoing probe into foreign dialysis kit makers including Fresenius, Nikkiso and Nipro.

Baxter International, Nikkiso America, Nipro, Fresenius Medical Care, Gambro

News Well, Dialysis, Exports

from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/13yyyjd

3D printing points to smarter cancer treatment

British researchers develop a new method using 3D printing to create personalized models of cancerous tissues.

(Reuters) — British scientists have developed a new use for 3D printing, putting it to work to create personalized replica models of cancerous parts of the body to allow doctors to target tumors more precisely.

Stratasys Inc.

News Well, 3D printing

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