By Yarmela Pavlovic and Jennifer Henderson
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dilluns, 30 de juny del 2014
FDA proposes enforcement discretion for medical device data systems
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Diabetes: New stents mean new alternatives to CABG
Newer drug-eluting stents may be just as safe as surgery for treating diabetic patients with arterial blockages, according to new clinical trial results.
Next-generation drug-eluting stents may present a new option for diabetic patients with heart disease, according to a new analysis spanning nearly 70 clinical trials.
Although earlier generations of stents didn't do so well, 2nd generation drug-eluting stents proved just as safe as coronary artery bypass grafting in patients with diabetes, who tend to have more aggressive heart disease and are more likely to need repeat treatment.
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InSightec seeks $50M for ultrasound tumor therapy
InSightec launches a $50 million Series D funding round in support of its MR-guided ultrasound treatment, hoping to boost the round to $62.5 million.
Israel-based InSightec is looking for a few investors to jump in on its $50 million Series D funding round, saying it'll use the funds to boost commercial efforts for its non-invasive tumor-targeting ultrasound therapy.
York Capital Management is already lined up to take a chunk out of the $50 million, leaving "limited time" for other prospective funders to jump in on the initial round or to expand fundraising to $62.5 million, InSightec said.
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Appeals court overturns Stryker win in Hill-Rom patent spat
A federal appeals court overturns Stryker's win over Hill-Rom in a patent spat over hospital bed monitoring systems.
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Press Release: EDAP completes FDA inspection of manufacturing site
LYON, France -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that the U.S. Food and Drug Administration (FDA) concluded its routine inspection of EDAP's manufacturing site with no findings nor issuance of Form 483 observations.
News Well, Press Release, Food & Drug Administration (FDA), Oncology, Pre-Market Approval (PMA), Prostate, Regulatory/Compliance, Ultrasound
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EDAP creeps toward FDA approval with clean inspection
FDA inspectors find no issues at EDAP's manufacturing facility, putting the company one step closer to winning premarket approval for its ultrasound-based prostate cancer treatment.
News Well, Food & Drug Administration (FDA), Oncology, Pre-Market Approval (PMA), Prostate, Regulatory/Compliance, Ultrasound
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Press Release: Encision receives FDA 510(k) approval on its AEM EndoShield burn protection system
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Edwards Lifesciences wins FDA nod for ClearSight monitor
Edwards Lifesciences says it won 510(k) clearance from the FDA for its ClearSight patient monitoring device.
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Stryker to pay $375M for Small Bone Innovations assets
Stryker agrees to acquire the Scandinavian Total Ankle Replacement device from Small Bone Innovations in a deal valued at $375 million.
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U.S. FDA relaxes regulatory requirements for medical device data systems
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 data systems (MDDS) used to support digital health technologies will no longer be required to comply with the US Food and Drug Administration's regulatory controls, according to new guidance from the agency.
News Well, Blog, Food & Drug Administration (FDA), Health Information Technology, Regulatory/Compliance
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Diabetes: Insulet settles Becton, Dickinson patent spat for $5M
Insulet says it agreed to settle a patent infringement lawsuit brought by Becton, Dickinson for $5 million.
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Healthcare's 'sloppy' with security, hacker says | MassDevice.com On Call
Too many hospitals have unsecured computer terminals that expose sensitive networks and leave every single internet enabled device vulnerable to hackers, researchers say.
MASSDEVICE ON CALL — Tasked with evaluating various hospitals' digital defenses, security expert and professional hacker Scott Erven found that sensitive networks are rife with vulnerabilities that could leave the entire system exposed.
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divendres, 27 de juny del 2014
FDA finalizes unique device identifier rules
The FDA puts the finishing touches on its unique device identifier program guidance, issuing a final rule that encompasses labeling, the UDI database and initial submissions.
The FDA today released the final version of its guidance regarding the new unique device identifier program, a new mandate that requires certain medical devices to have coded labels that make them trackable via a national database.
U.S. regulators issued a finalized rule that encompasses prior guidances into a single document, providing the final rules on the global UDI database, advice for initial submissions and other elements of the program.
News Well, Food & Drug Administration (FDA), Regulatory/Compliance, Universal Device Identifier (UDI)
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Press Release: Siemens files PMA for digital breast tomosynthesis
MALVERN, Pa. -- Siemens Healthcare has announced that it recently submitted to the U.S. Food and Drug Administration (FDA) its premarket approval application (PMA) for the MAMMOMAT Inspiration® with Breast Tomosynthesis option.
News Well, Press Release, Regulatory/Clearance, Breast Cancer, Food & Drug Administration (FDA), Mammography, Pre-Market Approval (PMA), Women's Health
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Thoratec launches HeartMate III trial
Thoratec says it's launched a clinical trial for its HeartMate III implantable heart pump it plans to useto back a bid for CE Mark approval in the European Union.
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Intersect ENT hopes to raise $80 million in newly registered initial public offering | Medtech funding for the week of June 23, 2014
Here's a look at some of the top funding stories for medical device companies this week: Intersect ENT registers $80M IPO for sinus implants; Mitralign raises another $8M; Device makers tally $67M in Pentagon deals; EndoShape raises $6.8M for vascular plugs and coils; EMBA Medical's still working on its $3M funding round
Intersect ENT registers $80M IPO for sinus implants
June 24, 2014 by Arezu Sarvestani
Welch Allyn, Digirad Corp., EMBA Medical, EndoShape Inc., Hologic Inc., iCad Inc., Intersect ENT Inc., InVivo Therapeutics Corp., Mitralign Inc., U.S. Defense Dept.
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EXCLUSIVE: Medtronic's strategy guru on the $43B Covidien buy
Geoff Martha, the executive in charge of integrating Medtronic's $43 billion Covidien acquisition, tells MassDevice.com that the deal will likely mean more strategic investments for the medical device giant.
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GPO Premier launches real-time medtech pricing app | MassDevice.com On Call
Premier cuts the ribbon on a new medical device pricing app that lets users access prices for thousands of medical devices in real time.
MASSDEVICE ON CALL — Medical device group purchasing giant Premier Inc. announced the launch of its PremierConnect Price Connect smartphone app, connecting healthcare providers with pricing on thousands of medical devices and supplies in real time.
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dijous, 26 de juny del 2014
FDA approves 1st exoskeleton to help paralyzed walk again
The FDA today announced breakthrough approval of the 1st motorized exoskeleton designed to help patients with lower body paralysis walk again.
FDA regulators announced this evening that they approved for the U.S. market the 1st robotic exo-suit for helping patients with lower-body paralysis walk upright.
Called ReWalk , the motorized system is comprised of metal leg braces that strap around the legs and back, supplying movement to joints in the hips, knees and ankles. The system includes a watch-based remote that controls the suit's movements and patients rely on crutches to provide stability.
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Boston startup raises $6M for heart monitoring bracelet
Whoop Inc. secures $6 million in equity financing in support of its sensor-embedded bracelet for continuous heart rate monitoring.
Boston-based fitness startup Whoop Inc. raised a stealthy $6 million this month from 14 unnamed investors, an SEC filing shows.
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Breakthrough tech lets paraplegic man move hand with only his thoughts
The pioneering NeuroBridge system bypasses spinal cord damage to help a paraplegic man move his hand on command, without the use of robotics or computers.
Researchers touted a major breakthrough this week when a paraplegic patients successfully moved his own hand using only signals from his own mind.
The technology is comprised of a microchip implanted in the brain and a "sleeve" laden with electrodes that stimulates the muscles in the arm in precise coordination with signals from the brain. Unlike other technologies that rely on robotics or computers to move paralyzed limbs, the so-called "NeuroBridge" system translates brain signals into muscle stimulation.
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Philips and Salesforce ally on healthcare IT
Philips and Salesforce unveil a healthcare IT partnership with 2 cloud-based products already ready for launch this summer.
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Dune Medical secures $14M for breast cancer detection
Dune Medical aims to boost its sales & marketing efforts with $21 million in equity financing that it hopes to raise before October.
Israeli imaging systems maker Dune Medical Devices touted the successful raise of $14 million in equity financing, looking to secure another $7 million before October to support its commercialization efforts.
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Wright Medical unveils Infinity total ankle replacement system in the U.S. | Medtech Wall Street news for the week of June 23, 2014
Here's a look at some of the top Wall Street stories for medical device companies this week: Wright Medical launches Infinity total ankle implant; Investors fire life science VC Burrill from his own fund; CareFusion hits new high, confirms layoffs and outsourcing to Mexico; Allergan urges shareholders to reject Valeant's $52B hostile takeover bid
Wright Medical launches Infinity total ankle implant
June 19, 2014 by Brad Perriello
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Study: Medtronic's Reveal XT bests conventional follow-up
A clinical study of Medtronic's Reveal XT cardiac monitor is superior to conventional follow-up in identifying atrial fibrillation after cryptogenic stroke.
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Digital disease detection: We see the trends, but who is actually sick?
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.
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Microsoft and Becton Dickinson team up in Israel | MassDevice.com On Call
Tech industry titan Microsoft teams up with Becton Dickinson to host a single class of healthcare startups at an accelerator in Israel.
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dimecres, 25 de juny del 2014
Press Release: Intuitive Surgical receives CE Mark for the da Vinci Xi surgical system
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Lantheus Medical plots IPO worth up to $125M
Lantheus Medical files registration forms ahead of an initial public offering worth up to $125 million in support of its diagnostic and imaging products.
Massachusetts-based Lantheus Medical Imaging announced today that it filed registration documents ahead of launching an initial public offering.
The company, which makes imaging agents and other diagnostic products, has yet to reveal share pricing or quantity, but set the maximum aggregate offering price at $125 million. Lantheus deals primarily in radiopharmaceutical and contrast agents, according to the prospectus summary.
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Google confirms Google Fit health and fitness tracking
Google today unveiled plans for its rumored foray into digital health and personal data tracking with the Google Fit platform, but offered few details on what that may entail.
True to the rumors, tech giant Google (NSDQ:GOOG) unveiled a previews of its Google Fit health and fitness tracking project, solidifying the company's vault into an arena that has been a major draw for consumer tech companies this year.
News Well, Conference coverage, Digital Health, Health Information Technology, Innovation, mHealth (Mobile Health)
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Report: Shareholders pick up the tab when Medtronic skirts taxes
Medtronic maintains that its $43 billion acquisition of Covidien and move to Ireland wasn't motivated by tax incentives, but the company is poised to save billions while the company's shareholders are left with a hefty tax of their own.
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Medtronic taps strategy exec to lead Covidien integration | Personnel Moves
Medtronic names Geoff Martha, its senior vice president for strategy & business development, as chief integration officer as it preps to digest the $43 billion Covidien acquisition.
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Mobile Health: Is Google Fit coming today? | MassDevice.com On Call
Google is hours away from launching this year's high-profile I/O conference, where the tech titan is expected to unveil its answer to Apple's HealthKit.
MASSDEVICE ON CALL — Technology giant Google(NSDQ:GOOG) is about to open the curtain on this year's I/O conference and analysts and insiders are projected a major foray into digital health.
News Well, On Call, Digital Health, Health Information Technology, Innovation, mHealth (Mobile Health)
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dimarts, 24 de juny del 2014
Press Release: Inogen announces FDA clearance of innovative home oxygen concentrator
GOLETA, Calif. -- Inogen, Inc. (Nasdaq:INGN) announced today that it has received FDA clearance for an innovative home oxygen concentrator called the Inogen At Home.
News Well, Press Release, Regulatory/Clearance, 510(k), Food & Drug Administration (FDA), Respiratory
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Inogen's poised for big things with newly cleared at-home oxygen system, Swann says
Wall Street analysts say Inogen is cornering the oxygen concentrator market with FDA clearance for its lighter, quieter Inogen At Home system.
Wall Street is looking for Inogen (NSDQ:INGN) to make a big splash with its new Inogen At Home oxygen concentration system, which won FDA clearance today.
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Press Release: NeuroMetrix receives marketing certification in Japan for NC-stat DPNCheck
Omron healthcare will distribute in Japan.
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Press Release: Abbott receives CE Mark for Tecnis Symfony extended range of vision intraocular lens for cataract patients
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Intersect ENT registers $80M IPO for sinus implants
California-based Intersect ENT files for an initial public offering worth up to $80 million in support of its drug-eluting implants for chronic sinusitis.
Drug-eluting devices maker Intersect ENT hopes to raise as much as $80 million in a newly registered initial public offering, according to SEC documents filed this week.
News Well, Drug-Device Combinations, Funding Roundup, Initial Public Offering (IPO), Otolaryngology/Ear, Nose & Throat (ENT)
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FDA wants another advisory panel hearing for BSX Watchman anti-stroke device | Regulatory news for the week of June 23, 2014
Here's a look at some of the top regulatory stories for medical device companies this week: FDA wants another panel hearing on Boston Scientific's Watchman anti-stroke device; FDA talks Twitter and other online etiquette for medtech makers; Malaysian medical device market regulators clarify, expand policies; FDA issues draft guidances for industry on social media and internet communications about medical products: Designed with patients in mind; Scotland curbs use of transvaginal mesh amid global outcry.
FDA wants another panel hearing on Boston Scientific's Watchman anti-stroke device
June 17, 2014 by Brad Perriello
Boston Scientific, C.R. Bard, Emergo Group, European Commission, Food & Drug Administration (FDA), Johnson & Johnson, Medicines & Healthcare products Regulatory Agency (MHRA)
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Covidien levels another lawsuit at Ethicon Endo over ultrasound shears
Covidien files another patent infringement lawsuit against Johnson & Johnson's Ethicon Endo-Surgery division over ultrasound shears technology.
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Cell therapy for early-onset inflammatory bowel disease?
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.
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Cell therapy for early-onset inflammatory bowel disease?
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.
Inflammatory bowel disease (IBD) is miserable for anyone, but when it strikes a child under age 5, it's much more severe, usually causing bloody diarrhea, wrenching abdominal pain and stunted growth. Early-onset IBD is rare, but on the rise: For reasons unknown, its incidence is increasing by about 5 percent per year in some parts of the world.
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Does the Medtronic-Covidien mega-merger leave startups in the cold? | MassDevice.com On Call
Medtech giants Medtronic and Covidien aren't likely to be very acquisitive after finalizing their $43 billion merger, taking 2 very important players out of the game for startup companies, venture capitalists say.
News Well, On Call, Medtronic buys Covidien, Mergers & Acquisitions, Minnesota, Venture Capital/Private Equity
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dilluns, 23 de juny del 2014
Device makers tally $67M in Pentagon deals
Hologic, Welch Allyn, InVivo, Digirad and ICAD claim nearly $67 million in medtech contracts with the Dept. of Defense.
The Defense Dept. handed out some $66.7 million in supply contracts to 5 medical device makers, covering Pap test kits, radiology and patient monitoring systems.
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ConvaTec in FDA hotseat after patients death, injuries
The FDA says that ConvaTec failed to seek 510(k) review for its recalled Flexi-Seal Control fecal management kit, which was associated with 12 injuries and 1 patient death.
Device maker ConvaTec landed in the FDA's cross hairs after the company recalled a device that the agency says never underwent regulatory review.
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Olympus accuses ex-sales manager, ArhtoCare | Medtech legal news for the week of June 23, 2014
Here's a look at some of the top legal news stories for medical device companies this week: Olympus goes after ex-sales manager, ArthroCare; Stryker alleges Medtronic colluded with patent troll for Kyphon IP; Investors fire life science VC Burrill from his own fund; Patient group wants J&J probe over pelvic mesh
Olympus goes after ex-sales manager, ArthroCare
June 16, 2014 by Brad Perriello
ArthroCare Corp., Burrill & Co., Corporate Action Network, IP Nav, Johnson & Johnson, Kyphon Inc., Medtronic, Olympus, Orthophoenix, Stryker Corp.
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Allergan urges shareholders to reject Valeant's $52B hostile takeover bid
Allergan urges its shareholders to reject Valeant Pharmaceutical's hostile takeover bid, valued at nearly $52 billion, saying the deal significantly undervalues Allergan.
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US FDA outlines plans for device review process improvements
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
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FDA cuts back oversight of medical device data systems | MassDevice.com On Call
FDA medtech regulators take a giant step back from their usual oversight of data systems that collect medical information from other devices.
MASSDEVICE ON CALL — Makers of medical device data systems caught a major break this month as FDA regulators ruled that devices that collect and store information generated by other devices can' skip the 510(k) process for premarket clearance.
The proposed change in regulation affects a wide range of devices, including wireless scales and glucose meters. The FDA defined "medical device data systems" as:
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divendres, 20 de juny del 2014
Continuing medical education: Pressure is up, and funding down. And neither is going away anytime soon
The Accreditation Council for Continuing Medical Education reveal trends taking place that point to growing areas of concern in Continuing Medical Education and training.
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