Valeant Pharmaceuticals boosts its unsolicited acquisition offer for Allergan to $53.3 billion, hoping to win shareholders with a steep premium.
eNeura has won FDA clearance since the making of this video.
eNeura's SpringTMS system is the 1st of its kind to use transcranial magnetic stimulation to depolarize neurons on the brain, a process that doctors believe may interrupt migraine activity. Designed for home use, patients place the device against the back of the head, where a magnetic pulse targets the occipital lobe.
Premia Spine CEO Ron Sacher confirms reports that the company has raised $7 million in a $10 million funding round in support of wider clinical trials for the company’s spinal plates.
Israeli device maker Premia Spine confirmed today that it had raised $7 million, planning on using part of the funds to pursue FDA approval for its spinal fixation devices.
CEO Ron Sacher told MassDevice.com today that the reports about the company’s latest fundraising efforts are true, and that Premia is looking to raise another $3 million to close out the financing round.
New study data suggests more patients may benefit from preventive stenting, even those with only moderate blockages in arteries.
Patients receiving an angioplasty after a heart attack may benefit from an extra procedure to place a stent in other narrowed arteries, even if blockages are only moderate, researchers said.
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
ALung Technologies raises another $10 million for its Hemolung respiratory assist device.
ALung Technologies said it drummed up another $10 million it plans to use to continue commercializing its Hemolung respiratory assist device.
Pittsburgh-based ALung's Hemolung device is an extracorporeal carbon dioxide removal system that works by removing carbon dioxide and delivering oxygen directly to a patient's blood via a small catheter inserted into the jugular or femoral vein.
Here's a look at some of the top funding stories for medical device companies this week: Mass. General gets $30M DoD grant to build brain implant for mental illness; Consano raises $3.9M to connect researchers with funders; M&A: Spectranetics prepares $200M offering to fund $230M AngioScore bid; EDAP outlines road to FDA approval for prostate cancer ultrasound therapy; Samsung dives into digital health with open platforms, $50M fund.
California-based Sensory Medical touts FDA clearance for its breakthrough Relaxis vibration therapy for treating restless leg syndrome.
FDA regulators this week cleared the 1st non-drug therapy for restless leg syndrome, Sensory Medical's Relaxis system.
Officials at CMS maintain that last month's unprecedented disclosure of hundreds of thousands of physician reimbursement records was a positive step forward to inject more transparency into U.S. healthcare.
Medicare officials released a statement this week defending the agency's decision to expose payments made to more than 880,000 physicians, saying that efforts to increase transparency pose more benefits than risks.
Verisante and Astoria agree to team up in a Polish joint venture to detect cancer in the upper gastrointestinal system.
Xlumena convinces U.S. healthcare regulators to downgrade pancreatic drainage stents to Class II status, lowering their risk category and level of regulatory oversight.
The FDA today issued a final order lowering the risk classification for pancreatic drainage stents at the request of device maker Xlumena.
The FDA agreed that Class II special controls are sufficient to ensure that new devices are safe and effective, taking pancreatic stents off of the more-stringent premarket approval system.
The consumer electronic giant launched new open hardware and software platforms to facilitate innovation in wearable health, and established a $50 million investment fund for innovators.
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 Charles Preston, M.D., MPH
Regulatory systems are essential for good health care because they ensure safe, high quality and effective medicines. However, these systems must be strengthened in many parts of the world — a subject that is a core effort of the Pan American Network for Drug Regulatory Harmonization (PANDRH).
A former engineer for Becton, Dickinson & Co. and C.R. Bard who was arrested last year confesses to stealing trade secrets concerning an injector pen.
French device maker EDAP TMS SA has a big month ahead as it pursues FDA approval for its Ablatherm-HIFU therapeutic ultrasound technology, preparing for regulatory inspections and launching a $9.3 million funding round.
Several medical device makers made cameo appearances in Minnesota's winning bid to bring the 2018 Super Bowl to the state.
MASSDEVICE ON CALL — The Minnesota Vikings highlighted some of their state's most prominent features in order to win over the Super Bowl selection committee, including some of the North Star State's most prominent medical device makers.
Obese patients who underwent bariatric surgery saw significant and sustained improvements in their Type II diabetes out to 3 years following the procedure, according to research from Johnson & Johnson's Ethicon.
Patients in a clinical study who had bariatric surgery saw sustained improvements in symptoms of Type II diabetes out to 3 years after the procedure, some reporting complete diabetes remission, researchers said.
Chinese regulators put their stamp of approval on Sorin Group's and MicroPort Scientific's joint venture for cardiac rhythm devices.
CardioMEMS lands breakthrough FDA approval for its Champion HF implantable heart monitor, the 1st device of its kind on the U.S. market.
FDA regulators today approved the 1st implantable heart monitor, CardioMEMS' Champion HF technology for remote patient monitoring.
The Champion HF system is comprised of a battery-free implant that sits permanently in the pulmonary artery, a catheter-based delivery system and a home communicator that acquires and processes signals from the device and routes it to healthcare providers.
Valeant Pharmaceuticals ups its unsolicited bid for Allergan by $10 per share to $58.50 apiece and says it will add a contingent value right for Allergan's Darpin eye drug worth $25 per share.
The dispute resolution panel slated to review the FDA's rejection of FzioMed's Oxiplex spinal surgery gel is postponed so the FDA can review additional data.
FzioMed said today that a dispute resolution panel slated for next month for its Oxiplex spinal surgery gel has been postponed so the FDA can review more clinical data.
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
Twitter-savvy physicians and researchers mull over the latest clinical results for Medtronic's renal denervation technology, calling for more common sense and less hype in treating hypertension.
Here's a look at some of the top personnel stories for medical device companies this week: Layoffs: Zimmer aims to 'keep everybody' following $13.3B Biomet mega-merger; Op-Ed: How to survive the Zimmer/Biomet merger; Echo Therapeutics proxy war gets ugly amid alleged threats.
Researchers at Massachusetts General Hospital are developing an implantable technology that may help treat mental illnesses, starting with combat veterans.
MASSDEVICE ON CALL — Researchers at Massachusetts General Hospital were recipients of a $30 million grant to build brain implants for treating mental illness, targeting combat veterans coming home with brain injuries, depression and post-traumatic stress disorder.
CardioKinetix says its Parachute left ventricular implant helped reshape the heart and reduce stress on its muscles in patients that have had a heart attack.
Results from the 1st patients treated with CardioKinetix's Parachute implant suggest that the device may be able to help reshape the heart following a heart attack, improving pumping.
Consano closes a $3.9 million funding round in support of its online platform for connecting donors with medical researchers.
Consano raised $3.9 million in 10 days in support of its mission to connect individual donors with vetted medical research projects.
Doctors and researchers at this year's EuroPCR conference look for answers in Medtronic's landmark SYMPLICITY HTN-3 clinical trial, which failed to find that renal denervation works against hypertension.
Amid the hand-wringing and back-pedaling surrounding renal denervation, some physicians are still looking for ways to use the technology to treat patients with hypertension.
Here's a look at some of the top regulatory stories for medical device companies this week: Bard wins FDA panel date for Lutonix balloon; Johns Hopkins and UCSF-Stanford join FDA's Centers of Excellence in Regulatory Science and Innovation; FDA warns CardiacAssist on unreported patient death; Building expertise and crossing boundaries to improve oversight; FDA warns on infant CPAP systems following dozens of complaints.
Here's a look at some of the top legal news stories for medical device companies this week: J&J's Conor MedSystems can't slip $100M Biotronik lawsuit; Supreme Court declines review of Baxter/Fresenius patent row; Medtronic, Edwards ink $750M heart valve settlement; Pa. Supreme Court to review $28M Zimmer verdict; Laid off Italian workers sue Haemonetics.
Former NBA player Jonathan Bender tries his hand at entrepreneurship, aiming to bring the physical therapy device he invented to the U.S. market.
Joint pain cut years from Jonathan Bender's professional basketball career, but it also gave him a future.
The former NBA player, who made the jump from high school directly to the pros in 1999, spent 7 injury-plagued seasons with the Indiana Pacers before bowing out in 2006 (Bender returned in 2010 for a half season with the New York Knicks).
Despite leadership's promises to "keep everybody" after the Zimmer/Biomet mega-merger, executive search & consulting expert Drue DeAngelis is certain that deep cuts are on the way.
FDA regulators put their highest-risk warning on Fisher & Paykel Healthcare's recall of infant CPAP prongs after receiving complaints that they detached from their tubing.
FDA regulators put their highest-level warning on Fisher & Paykel's recall of infant CPAP components, warning that the defect may pose a choking risk to babies.
eNeura's SpringTMS system uses magnetic stimulation to relieve pain associated with migraines that are preceded by an aura.
Maryland medical device maker eNeura today touted FDA clearance for its SpringTMS system, a mobile magnetic stimulator that can help relieve pain associated with migraines that are preceded by an ‘aura.'
SpringTMS is the first medical device available to patients in the United States to relieve the pain caused by migraine headaches that are preceded by an aura.
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.
Here's a look at some of the top funding stories for medical device companies this week: HistoSonics nears close of $14.2M funding for non-invasive ablation; Israel-based Keystone Heart raises $14M for cerebral protection; Ceterix Orthopaedics raises $18M for surgical tools; Allied Minds prepares $140M U.K. IPO to support U.S. R&D; mHealth: iRhythm raises $17M for Zio wearable monitor.
St. Jude Medical says that its next-gen EnligHTN renal denervation system appears safe and effective in treating hypertension, but docs at this year's EuroPCR conference are calling for more robust clinical trials.
San Francisco-based iRhythm Technologies secures $17 million in in Series E funding in support of its wearable Zio heart monitor.
Remote monitoring startup iRhythm touted a new $17 million Series E funding round in support of its wearable devices, saying it plans to pursue efforts in commercialization, marketing and clinical studies.
The San Francisco company offers continuous cardiac monitoring with its FDA-cleared Zio wearable device and accompanying software. The system is designed to log data on patients' heart rhythms, then process and analyze the data to kick out a report for physicians.
EDAP TMS lands a July date with FDA advisors to review therapeutic ultrasound in treatment of localized prostate cancer.
France-based EDAP TMS SA will get its day with the FDA next month, when the agency's expert advisors will review EDAP's Ablatherm-HIFU therapeutic ultrasound technology for treatment of prostate cancer.
FDA regulators issue a formal warning letter against CardiacAssist after inspectors find that the company failed to report a patient death.
Pennsylvania-based CardiacAssist landed in the FDA's cross hairs this month after agency inspectors found that the company failed to file a report after learning of a patient death.
Symmetry Medical sells off its British aerospace subsidiary, Clamonta Ltd., for roughly $1.3 million.
Symmetry Medical's (NYSE:SMA) said today that it sold its Clamonta Ltd. aerospace subsidiary to the HLDF Corp. for roughly $1.3 million (£0.8 million), but remains committed to the aerospace machining market.
Here's a look at some of the top Wall Street stories for medical device companies this week: Is Boston Scientific's peripherals buy bad news for Cardiovascular Systems?; M&A: Medtech makers use acquisitions to fill niches; Report: Deals in the medical device sector rose 200% in Q1; CareFusion plans $1B debt offering; Activist investor Oracle revives proxy war at Biolase.
