onmedic news: de novembre 2014

dimecres, 26 de novembre del 2014

Neuromod wins CE Mark for tinnitus device

Dublin-based Neuromod Devices says it won CE Mark approval in the European Union for its new multi-sensory device to treat tinnitus.

Dublin-based Neuromod Devices said it won CE Mark approval in the European Union for its new multi-sensory device to treat tinnitus, also known as "ear-ringing."

The product, mutebutton, is a handheld device that helps the brain distinguish between real and phantom noises through audio and tongue stimulation.

Neuromod Devices

News Well, CE Mark, Neuromodulation/Neurostimulation, Regulatory/Compliance

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Hansen Medical's Magellan used in 1st robotic prostate embolization

Hansen Medical touts its Magellan robotic surgical device in the first successful robotic prostatic artery embolization in the U.S.

Hansen Medical Inc.

News Well, Urology, Robot-Assisted Surgery

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X2 Biosystems raises $4m in debt offering

Brain injury device developer X2 Biosystems sells approximately $4.2 million in debt and securities under a previously filed $9 million offering, according to a regulatory filing.

Brain-injury device developer X2 Biosystems said it sold approximately $4.2 million worth of debt and securities under a previously filed $9 million offering.

X2 Biosystems

News Well, Funding Roundup, Neurological, Trauma

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Study: No benefit for mitral valve replacement alongside CABG

New data released by The Cardiothoracic Surgical Trials Network raises questions about adding mitral valve repair to coronary artery bypass graft procedures in patients with moderate ischemic mitral regurgitation.

New clinical trial data challenges the usefulness of adding mitral valve repair to coronary artery bypass grafting in patients with moderate ischemic mitral regurgitation.

American Heart Assn.

News Well, Coronary Artery Bypass Graft, Replacement Heart Valves

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Philips wins FDA clearance for IQon Spectral CT system

Royal Philips wins 510(k) clearance from the FDA for its IQon Spectral CT system for enhanced computed tomography imaging.

Philips wins FDA approval for IQon Spectral CT system

Royal Philips (NYSE:PHG) said it won 510(k) clearance from the FDA for its IQon Spectral CT system for enhanced computed tomography imaging.

Food & Drug Administration (FDA), Philips Healthcare

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

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Diabetes: Tandem inks Tidepool deal

Tandem Diabetes teams with a non-profit to boost access to a diabetes data through an open-source software platform.

Tandem Diabetes Care Inc., Tidepool

News Well, Diabetes, mHealth (Mobile Health)

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Abaxis buys UK distributor

Abaxis says it bought QCR & Trio Diagnostics, the company's distribution partner for veterinary products in the U.K. and Ireland.

Abaxis said it bought QCR & Trio Diagnostics, its distribution partner for veterinary products in the U.K. and Ireland.

The deal closed on Nov. 17, Abaxis said. Financial terms were not disclosed.

Abaxis Inc.

News Well, Distribution, Mergers & Acquisitions, Veterinary

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FDA OKs Cerus trial of Intercept blood device for Ebola patients

The FDA OKs Cerus Corp.'s Intercept blood system in processing plasma from Ebola survivors as a possible treatment for the deadly virus.

Cerus Corp., Food & Drug Administration (FDA)

News Well, Investigational Device Exemption (IDE), Ebola

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Seizure-detecting wristwatch moves forward: Embrace

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

This Thanksgiving week, as Epilepsy Awareness month closes out, we're gratified to see an innovation tested here at Boston Children's—a wearable device for patients with epilepsy—move toward commercial development. Called Embrace, it's like a "smoke alarm" for unwitnessed seizures that could potentially prevent tragic cases of sudden, unexpected death from epilepsy (SUDEP):

Boston Children's Hospital

News Well, Vector Blog, Big Data, Blog

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DAPT funk: Study raises questions about Boston Scientific's Synergy stent

Researchers for the massive DAPT study find that drug-eluting stents may be safer than bare-metal stents, calling into question the value of Boston Scientific's next-gen Synergy stent.

Researchers for the massive Dual Anti-platelet Therapy Study found that patients receiving drug-eluting stents had a lower rate of stent thrombosis and other major cardiovascular events than those treated with bare-metal stents, undermining the common perception that bare-metal stents are safer.

Boston Scientific, American Heart Assn.

News Well, Stents

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dimarts, 25 de novembre del 2014

HCA hospitals halt use of uterine fibroid surgical tool

HCA Holdings halts the use of laparoscopic power morcellators in uterine fibroid surgeries in all 278 of its facilities, after the FDA raises the warning level on the cancer risk associated with the devices.

(Reuters) — HCA Holdings (NYSE:HCA), the largest for-profit U.S. hospital operator, said a procedure for removing uterine fibroids that's been linked to the spread of cancer will no longer be performed at its facilities.

HCA Holdings

News Well, Gynecological, Wall Street Beat

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Vascular Solutions wins FDA nod for Gel-Block embolization foam

Vascular Solutions says the FDA granted 510(k) clearance for its Gel-Block embolization foam.

Vascular Solutions wins FDA nod for embolization foam

Food & Drug Administration (FDA), Vascular Solutions Inc.

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

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Plaintiffs in Bard's pelvic mesh MDL want cases tried together

The plaintiffs in 185 lawsuits filed against C.R. Bard over its Avaulta pelvic mesh as part of a multi-district litigation want their cases tried together.

Boston Scientific, C.R. Bard

Legal News, News Well, Gynecological, Pelvic Mesh Lawsuits

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Medical device tax pushes B. Braun to spike HQ expansion plans

B. Braun spikes its plan to expand its headquarters to absorb the annual $13 million hit it takes from the medical device tax, CEO Caroll Neubauer tells MassDevice.com.

B. Braun Medical is spiking its plan to expand its Pennsylvania headquarters due to the medical device tax, CEO Caroll Neubauer told MassDevice.com last week.

B. Braun Medical Inc.

News Well, Medical Device Tax

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BD plans to use more cash, less debt for $12B CareFusion buy

Becton Dickinson plans to cut the debt load from its $12 billion acquisition of CareFusion by some $1.4 billion after realizing it has more cash available that it thought.

Becton Dickinson & Co., CareFusion Corp.

News Well, Funding Roundup, Mergers & Acquisitions

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The importance of being scrappy: Tips from med tech entrepreneur Amar Sawhney

Ocular Therapeutix CEO Amar Sawhney talks to S2N Health about how a little bit of scrap can lead to a lot of wins for medtech startups

By Amy Siegel, S2N Health

Ocular Therapeutix Inc., S2N Health

News Well, Venture Capital/Private Equity

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Convicted ex-ArthroCare CEO Baker wants new trial

Ex-ArthroCare CEO Michael Baker wants a new trial after being sentenced to 20 years in prison for his part in a scheme to defraud investors.

ArthroCare Corp.

Legal News, News Well

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Bill would curb FDA oversight of EHRs

A draft bill making the rounds in Washington would curb the FDA's oversight of electronic health records and some clinical support software.

(Reuters) — A draft bill is circulating in Washington that would curb the FDA's oversight of electronic medical records and some clinical support software, according to a copy of the legislation seen by Reuters.

U.S. Congress

News Well, Capitol Hill, Electronic Medical Records

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China Journal: strengthening relationships to protect public health

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 Margaret A. Hamburg, M.D.

I am just about to wrap up a jam-packed five-day visit to China, a fascinating country with a dramatically growing economy and with an increasingly significant impact on the products that Americans consume. Indeed, a key reason for my trip is the important and growing collaboration between FDA and our counterpart agencies in China to ensure the safety of the large volume of foods and medical products exchanged between our two nations.

Food & Drug Administration (FDA)

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

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dilluns, 24 de novembre del 2014

Polaris Partners raises $450m for new healthcare fund

Polaris Partners raises a $450 million fund to invest in healthcare and high technology.

(Reuters) — Venture capital firm Polaris Partners said today that it raised $450 million for its 7th fund, which will invest in healthcare and technology startups.

Polaris Partners

News Well, Venture Capital/Private Equity

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HHS hits Covidien with subpoena over peripheral devices

Covidien says it received a subpoena from the inspector general of the U.S. Health & Human Services Dept. over some of its peripheral vascular devices.

HHS grills Covidien over peripheral devices

Covidien, Dept. of Health & Human Services (HHS)

Legal News, News Well, Peripheral Artery Disease

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Covidien wins FDA nod for Fortrex PTA balloon catheter

Covidien says it won 510(k) clearance from the FDA for its Fortrex PTA balloon catheter, designed both for maintaining blood vessel access for hemodialysis and for treating peripheral artery disease.

Covidien, Food & Drug Administration (FDA)

News Well, 510(k), Dialysis, Peripheral Artery Disease, Regulatory/Compliance

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Zoll Medical seeks Japan's O.K. for temperature management tech

Zoll Medical wants Japanese regulatory approval to use its intravascular temperature management system to treat sudden cardiac arrests.

Zoll Medical wants to use its temperature management technology in Japan to treat sudden cardiac arrests, a new indication in that country for a system designed to cool or warm patients.

Zoll Medical Corp., Japanese Pharmaceuticals and Medical Devices Agency

News Well, Exports, Regulatory/Compliance, Temperature Management

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Boston Scientific backs Iowa Approach's atrial fibrillation device

Iowa Approach says it landed an investment from Boston Scientific for the ablation device it's developing to treat atrial fibrillation.

Boston Scientific, Iowa Approach

News Well, Cardiac Rhythm Management, Funding Roundup

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Reva Medical raises $25m for Fantom bioabsorbable stent

Reva Medical closes a debt-and-options round worth $25 million to back the clinical program behind its Fantom bioabsorbable stent.

Reva Medical Inc.

News Well, Bioabsorbable Stents, Funding Roundup

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FDA adds 'black box' warning to power morcellator labels

The FDA adds a 'black box' warning to the labels on laparoscopic power morcellators, advising against their use in most women slated for fibroid surgery.

FDA adds warnings to power morcellator labels

The FDA today put so-called "black box" warnings on the labels for laparoscopic power morcellators advising doctors that the devices, until recently a mainstay of gynecological surgery, be avoided in nearly all fibroid-removal procedures.

Food & Drug Administration (FDA)

News Well, Gynecological, Regulatory/Compliance

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Second Sight Medical's IPO grosses $36m

Second Sight Medical's initial public offering last week raised more than $36 million after its underwriter picked up an over-allotment option.

Second Sight Medical Products Inc.

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

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InfoBionic raises $17m for could-based patient monitoring system

InfoBionic closes the 2nd tranche of its $17 million Series B financing, attracting interest from Excel Venture Management and a Blue Cross Blue Shield subsidiary.

An investment subsidiary of Blue Cross Blue Shield of Massachusetts signed on for the 2nd tranche of InfoBionic's $17 million Series B financing. The Lowell, Mass.-based startup plans to use the cash infusion to commercialize its cloud-based remote patient monitoring system in the U.S. and Europe.

InfoBionics

News Well, Funding Roundup, Remote Patient Monitoring

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FDA approves Avantis Third Eye Panoramic colonoscopy device

The FDA approves Avantis Medical Systems' Third Eye Panoramic digital imaging device for colonoscopies.

Avantis Medical Systems said the FDA approved its Third Eye Panoramic digital imaging device for colonoscopies.

Avantis Medical Systems Inc., Food & Drug Administration (FDA)

News Well, 510(k), Gastrointestinal, Imaging, Regulatory/Compliance

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Pelvic mesh trial losses pressure Boston Scientific

Back-to-back losses in pelvic mesh lawsuits could drive up the cost – and urgency – of settling thousands of other such cases for Boston Scientific, legal experts say.

Boston Scientific, C.R. Bard, Endo Health, Ethicon Inc., Johnson & Johnson

Legal News, News Well, Pelvic Mesh Lawsuits

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DNA paired with light could help guide drugs to their targets

Short snippets of DNA called aptamers (red) readily get into cancer cells (green and blue) on their own (left panel). They can't penetrate cells when stuck to an oligonucleotide (center), but regain the ability when the oligonucleotide's bonds are broken by UV light (right). (Images courtesy Lele Li, PhD.)

By Tom Ulrich

Boston Children's Hospital

News Well, Vector Blog, Big Data, Blog

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divendres, 21 de novembre del 2014

US FDA delays UDI compliance deadline for some single-use implantable 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

Medical device regulators in the US have extended their Unique Device Identification compliance deadline to September 24, 2016 for some implantable medical devices to provide more time for manufacturers of these devices to develop and implement workable UDI processes.

In order to qualify for the extension, a device must meet three key criteria:

Emergo Group

News Well, Emerging Markets, Regulatory/Compliance

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BrainScope wins FDA clearance for Ahead 100 brain-injury scanner

BrainScope wins U.S. regulatory clearance for its Ahead 100 device for detecting traumatic brain injury.

BrainScope wins FDA approval for Ahead 100 brain-injury scanner

BrainScope said it won 510(k) clearance from the FDA for its Ahead 100 device, designed to detect traumatic brain injury.

BrainScope Company Inc., Food & Drug Administration (FDA)

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

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Could cyber crooks really hack your pacemaker?

Pacemakers get hacked on TV, but could it happen in real life?

Kaiser Health News — Jay Radcliffe breaks into medical devices for a living, testing for vulnerabilities as a security researcher.

He's also a diabetic, and gives himself insulin injections instead of relying on an automated insulin pump, which he says could be hacked.

News Well, Cybersecurity/Hacking

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BD-CareFusion deal passes US anti-trust waiting period

Becton Dickinson's $12.2 billion bid for device maker CareFusion clears the required waiting period under U.S. anti-trust regulations.

Becton Dickinson & Co., CareFusion Corp.

News Well, Mergers & Acquisitions

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Startup Aortica raises $7m in Series A round, names Douthitt CEO

Aortica raises $7 million in a Series A funding round for its customized abdominal aortic aneurysm device and names medtech veteran Tom Douthitt as its new CEO.

Aortica raises $7m in Series A round, names new CEO

Aortica said it raised $7 million in a Series A round for development of its treatment for abdominal aortic aneurysms and named a medtech veteran as its new CEO.

Aortica said medtech veteran Tom Douthitt will helm the corner office, with co-founder Dr. Ben Starnes serving as chief medical officer.

Aortica

News Well, Endovascular, Funding Roundup

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Philips Respironics Esprit ventilator recall is Class I

The FDA slaps a Class I label on Philips Respironics' recall of its Esprit V1000 and V200 ventilators, over concerns that machines may fail to operate on AC power.

Philips Healthcare, Respironics Inc.

News Well, Recalls, Respiratory

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Baxter IV container recall is Class I

The FDA slaps a Class I recall label on Baxter International's pullback of tainted containers used to prepare intravenous medicines.

Baxter's (NYSE:BAX) recall of tainted containers used to prepare intravenous medicines is drawing heightened FDA scrutiny. The regulatory agency slapped a Class I label on the effort, its most serious designation.

Baxter International, Food & Drug Administration (FDA)

News Well, Recalls

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Justice Dept. recoups $6B in False Claims Act cases

The U.S. Justice Dept. says it recouped nearly $6 billion from civil cases alleging fraud and false claims against the federal government, including $2.3 billion from healthcare cases.

The U.S. Justice Dept. said it recouped a record $5.69 billion in settlements and judgments from False Claims Act cases during the fiscal year ended Sept. 30, including some $2.3 billion in recoveries from healthcare cases.

Boston Scientific, Dept. of Justice (DOJ)

Legal News, News Well, Cardiovascular

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My interview at AHA 2014 on ABIM's Maintenance of Certification Program

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

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dijous, 20 de novembre del 2014

Australia and New Zealand abandon plan for single medical regulatory agency

By Stewart Eisenhart, Emergo Group

The governments of Australia and New Zealand no longer plan to form a joint regulatory authority to oversee both countries' medical device markets.

Emergo Group

News Well, Emerging Markets, Regulatory/Compliance

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Will Orange County's medtech scene lose its juice without Allergan?

Will the $66 billion buyout of Allergan by Actavis suck some of the juice out of Orange County, Calif., which Allergan's called home for 60 years?

Actavis, Alphaeon, Masimo, Valeant Pharmaceuticals, Allergan Inc.

News Well, DeviceTalks, Mergers & Acquisitions

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Boston Scientific to pay $18.5m in pelvic mesh case

Boston Scientific goes down in another product liability lawsuit over its pelvic mesh products.

Boston Scientific

Legal News, News Well, Pelvic Mesh Lawsuits

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Medical device marketing in a post-Obamacare world

What's a medical device company to do when Facebook and Twitter can spread word of its products better than any marketing campaign ever could?

keys:

Medical device marketing in a post-Obamacare world

Medical device manufacturers are facing a shrinking number of buyers and an increasingly sophisticated healthcare world, in which Twitter and Facebook may spread word of their products more swiftly than any marketing campaign.

LifeScience Alley

News Well, Marketing/Public Relations

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Medtronic CEO Ishrak defends Covidien deal

Medtronic CEO Omar Ishrak, speaking yesterday at LifeScience Alley's annual convention in Minneapolis, defends the pending $43 billion Covidien acquisition.

LifeScience Alley, Medtronic

News Well, Medtronic buys Covidien

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Second Sight CEO Greenberg: Next-gen 'bionic eye' could treat nearly all forms of blindness

Second Sight Medical, which yesterday saw its initial public offering close up nearly 122%, could have its next-generation 'bionic eye' device ready for nearly all blind patients 'within a couple of years,' CEO Dr. Robert Greenberg tells MassDevice.com.

Second Sight Medical CEO Greenberg: Next-gen bionic eye could treat nearly all forms of blindness

Second Sight Medical Products Inc.

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

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Bard still on the hook for its share of $5m pelvic mesh verdict

A California appeals court upholds a $5 million judgment against C.R. Bard and the surgeon involved in a product liability lawsuit filed over its Avaulta pelvic mesh.

C.R. Bard

Legal News, News Well, Pelvic Mesh Lawsuits

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Shares soar for InVivo after spinal cord study update | Medtech Wall Street news for the week of November 17, 2014

Here's a look at some of the top Wall Street stories for medical device companies this week: InVivo shares soar on spinal cord study update; Actavis trumps Valeant with $66B offer for Allergan; Medtronic's Q2 results meet The Street; Venture capital investment in medtech grows in Q3

InVivo shares soar on spinal cord study update

November 13, 2014 by Val Kennedy

Actavis, InVivo Therapeutics Corp., Medtronic, National Venture Capital Assn. (NVCA), Pershing Square Capital Management, PricewaterhouseCoopers (PwC), Thomson Reuters, Valeant Pharmaceuticals, Allergan Inc.

News Well, Wall Street Beat

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More changes at Hologic as it axes administrative chief Casey | Personnel Moves

Hologic fires its chief administrative officer, Mark Casey, effective Dec. 19.

Acelity, Cheetah Medical, Cor Medical Technologies, Dynatronics Corp., Hologic Inc., Invacare Corp., Medical Device Manufacturers Assn. (MDMA), MELA Sciences Inc., NxThera Inc., Vision-Ease Lens

News Well, Personnel Moves

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dimecres, 19 de novembre del 2014

The wonders of role reversal

By Westby G. Fisher, MD, FACC

Another day, another pacemaker, at least so it seemed at first.

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

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FDA working to keep patients well informed

By Steve L. Morin R.N., B.S.N.

Food & Drug Administration (FDA)

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

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IlluminOss wins FDA nod for bone fracture device trial

IlluminOss Medical says the FDA cleared a clinical trial of its photodynamic bone stabilization system for treating upper arm fractures due to metastatic cancer.

$IlluminOss wins FDA nod for bone fracture device trial$

IlluminOss Medical said the FDA granted "conditional" clearance for a clinical trial of its photodynamic bone stabilization system, ahead of its bid for de novo clearance from the watchdog agency.

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

News Well, Clinical Trials, Orthopedics

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Cardica plunges after pulling MicroCutter Xchange 30 stapler

Cardica shares plunge after it suspends the launch of its MicroCutter Xchange 30 surgical stapler so it can focus on improving the product, a move that may also result in a realignment of its operations.

Broadfin Capital, Cardica Inc.

News Well, Surgical, Wall Street Beat

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