Kona Medical announces the launch of a clinical trial for its non-invasive Surround Sound renal denervation device for treating hypertension.
Kona Medical said this week that it's launched a clinical trial of the non-invasive renal denervation device for treating hypertension it calls Surround Sound.
Boston Scientific reportedly wins the 2nd bellwether trial over its Obtryx pelvic mesh device, a month after winning the 1st personal injury case to go to trial over its transvaginal sling devices.
Massachusetts Congressional challenger Seth Moulton vows to fight against the medical device tax, putting fellow Democrat and long-time House incumbent John Tierney on blast.
The medical device tax has long been a rallying point for lawmakers on the right, but the levy is making a cameo appearance in a fight among Democrats looking to represent Massachusetts' 6th District.
Arthrex outbids nearly 60 competitors to win a contract with the U.S. Defense Dept. that's worth $255 million.
Arthrex won a Pentagon contract worth $255 million, beating out nearly 60 other bidders for the deal, the U.S. Defense Dept. said yesterday.
The 5-year base contract for "medical items and accessories" went through a competitive bidding process that included bids from 57 other companies, the Pentagon said.
Baxter International says it will keep its headquarters in Illinois, despite recent reports of a possible move to Boston, but stays coy on its actual plans in The Hub.
Here's a look at some of the top legal news stories for medical device companies this week: Wearable Intelligence raises $8M for healthcare Google Glass; Healthsense expands with $10M for remote monitoring; Advanced Catheter Therapies boosts funding to $4.5M amid high interest; Funding: Medtech VC jumps in Q2, but not for early-stage companies; Advanced Cooling Therapy secures $1.5M for temperature management
Medtronic reveals that the tax tab for its top executives from its Covidien buyout will near $58 million, apart from the capital gains taxes all shareholders will pay on the $43 billion deal.
Surgical repair of hip fractures costs more up-front but saves $65,000 in healthcare costs down the line, according to a study backed by the American Academy of Orthopedic Surgeons.
Hip surgeries are likely to become increasingly popular as the U.S. population ages, representing a significant cost burden for the healthcare system, but orthopedic surgeons say the procedure ultimately saves tens of thousands of dollars per patient.
California's Sequent Medical begins enrolling patients in an IDE clinical trial of its Web aneurysm embolization system.
Medtech company Sequent Medical enrolled the 1st 4 patients in a new U.S. clinical trial aimed at winning FDA approval for its Web aneurysm protection implant.
The Web implant is made of a Nitinol mesh that is delivered in a "stent-like" manner and deployed into the pouch formed by an aneurysm in order to prevent blood from flowing in. The device already has approve in the European Union.
The federal government won't release data next month on some research payments to doctors. Health officials had acknowledged previously that the database wouldn't include one-third of payments made by pharmaceutical and medical device companies.
by Charles Ornstein, ProPublica
Apple issues new privacy rules to prevent makers of app-makers from selling health data collected through the tech giant's new HealthKit platform.
MASSDEVICE ON CALL — Tech titan Apple (NSDQ:AAPL) made some recent changes to its app-developer guidelines in order to protect patient data collected through its highly anticipated HealthKit platform, slated to hit the market later this year.
Utah incubator Surgical Frontiers plans to invest in musculoskeletal startups with its new $7 million fund.
Surgical Frontiers is looking to make investments in young musculoskeletal technology companies with the $7 million fund it just secured.
The company has already promised some of the cash to 3 portfolio companies with orthopedic technologies in foot & ankle, sports medicine and trauma, the company said.
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.
The FDA flags Vention Medical for violations found during an inspection last spring of a plant in Costa Rica.
The FDA last month slapped Vention Medical with a warning letter over conditions at a plant in Costa Rica, flagging problems with the medical device company's procedures there.
The July 1 letter was prompted by an FDA inspection in March of a plant in Barreal de Heredia, Costa Rica, the FDA said.
Zimmer Holdings wants a federal judge to impose sanctions against the lawyers in 3 cases from the multi-district litigation filed over its knee implants, claiming that the cases should never have been brought in the 1st place.
CorMatrix secure FDA clearance for its CanGaroo ECM envelope for use with implantable cardiac devices and touts 1st human use in a patient at Ohio's Cleveland Clinic.
Georgia medical device maker CorMatrix touted an FDA win this month, landing regulatory clearance for its CanGaroo surgical envelope for securing implantable cardiac devices.
Roswell, Georgia – CorMatrix Cardiovascular announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market the CorMatrix CanGaroo ECM Envelope for use with cardiac implantable electronic devices (CIED's) including pacemakers and implantable cardioverter defibrillators (ICD's).
First noninvasive total haemoglobin (SpHb) spot-check sensor for infants and small children.
Here's a look at some of the top Wall Street stories for medical device companies this week: Covidien snaps up Reverse Medical; Standard & Poor's maintains credit watch on Medtronic over Covidien buy; Allergan can't delay shareholder vote on hostile Valeant bid; Medtronic drops $200M on Dutch DBS firm Sapiens; Nobel Biocare's Q2 profits double as it fields buyout interest
GI Dynamics names ex-ATS Medical chief Michael Dale to replace Stuart Randle as CEO.
Medtronic says it won U.S. clearance for its Shilla growth guidance system, a spinal implant designed to accommodate children's growth as it corrects their early-onset spinal deformities.
Image courtesy Medtronic. Click to enlarge.
A lawsuit filed by a former Stryker Corp. sales rep over alleged reimbursement failures wins class action status for all reps employed between February 2009 and October 2012.
Covidien acquires Sapheon and its minimally invasive VenaSeal device for treating varicose veins for an undisclosed amount.
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.
A federal appeals court upholds the U.S. Patent & Trademark Office's decision not to review 8 defibrillator patents owned by Philips Healthcare and dismisses the case.
Georgia-based Theragenics has about 50 new positions to fill as it prepares to begin manufacturing in Costa Rica. The company cut nearly 140 workers from its Texas-based Galt Medical operations earlier this year.
Surgical devices maker Theragenics is looking to add some employees overseas at it prepares to ramp up manufacturing at a new facility in Costa Rica, part of larger outsourcing plans that included cuts in the U.S.
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.
As I begin another year teaching EKG's to our new residents, I find I am increasingly asking myself "Where to teach?"
Botox-maker Allergan acquiesces to Valeant Pharmaceuticals' demands for a special shareholder meeting, but takes to court to prevent Valeant and its compatriots from voting their shares.
The FDA puts its highest-risk Class I label on the recall of DePuy Synthes' jaw stabilizing system over a defect that may result in injury or death in infants.
FDA regulators put their highest-risk Class I label on the recall of DePuy Synthes' Craniomaxillofacial Distraction System after the company reported 15 injuries associated with the jaw implant.
Yet another shareholder sues Covidien and its leaders, accusing them of short-changing investors in the $43 billion acquisition by Medtronic.
Exo-suit maker ReWalk Robotics boosts its max offering price and epilepsy NeuroSigma registers for a $50 million initial public offering.
Two medical device makers are preparing initial public offerings for the coming weeks, breaking up a spree of biotech IPOs that have dominated the market.
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
A federal judge agrees to toss a lawsuit filed against Johnson & Johnson's Biosense Webster by a former sales rep and her new employer, St. Jude Medical.
Total venture capital dollars invested in medical device companies jumped more than 20% during the 2nd quarter, but early-stage companies are still out in the cold.
Life science venture capital funding saw a major boost in the 2nd quarter as public markets smiled on biotech companies, but medical device makers saw a significant boost of their own – as long as they weren't early-stage firms.
St. Jude Medical says the FDA cleared a 2009 warning letter issued over a plant in Plano, Texas, that makes neuromodulation devices.
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 David G. White, Ph.D.
Advanced Cooling Therapy plans full commercial launch after closing its $1.5 million funding round.
Chicago-based Advanced Cooling Therapy is planning to break onto the market now that it's closed a $1.5 million Series A funding round.
ACT is building up to full commercial launch of its Esophageal Cooling Device, which has approval from European and Canadian regulators. The device is not yet cleared for the U.S.
Medtronic and Covidien reveal the line-up of leaders slated to guide integration of the companies' regional divisions ahead of their $43 billion merger.
Texas-based mobile health company AirStrip aims to expand into home care and to boost its global presence with $25 million raised from new and existing investors.
AirStrip is looking to broach some new ground with the $25 million it just raised in support of its mobile healthcare technologies.
The Texas company plans to expand into home health, boost internationalization efforts and pursue some new analytics partnerships in combination with advancing its flagship AirStrip One platform.
Medtronic CEO Omar Ishrak tells employees that its pending combination with Covidien lays the table for taking a 40% share of the patient monitoring market.
Here's a look at some of the top regulatory stories for medical device companies this week: Philips wins FDA nod for 3D TAVI planning software; Direct Flow wins CE Marks for TAVI device; FDA OKs return of Covidien's Pipeline embolism device; FDA delays UDI rule for contacts, intraocular lenses; Cardiovascular Systems recalls some Diamondback devices on embolism risk
An FDA advisory panel is slated to convene yet again in October to consider the safety and efficacy of Boston Scientific's Watchman anti-stroke heart repair device.
Medtronic pays $200 million in cash for Sapiens Steering Brain Stimulation, a Dutch firm that makes deep-brain stimulation devices for treating neurological conditions.
Advanced Catheter Therapies expands its Series B funding round to $4.5 million after surpassing its original $3 million mark.
Tennessee-based medical device maker Advanced Catheter Therapies pushed the cap on its Series B funding round after generating more interest that it expected.
The company is now looking to raise $4.5 million where it had previously sought $3 million in support of its catheter-based endovascular drug delivery technology.
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 Ed Anderson
There's no way around it. Obtaining approval to market a new drug is lengthy, complex, costly and fraught with uncertainty and risk. Financial engineers at MIT propose a strategy to minimize that risk – one that deserves a close look.
Doctors at a Chinese University implant a 3D-printed vertebra for the 1st time in a 12-year-old patient with a malignant tumor on his spinal cord.
MASSDEVICE ON CALL — In a breakthrough surgery a team of physicians at Peking University implanted a 3D-printed vertebra for the 1st time in a 12-year-old boy with a malignant tumor on his spinal cord.
Nobel Biocare sues Brazilian rival Neodent, alleging infringement of 2 patents covering its NobelActive dental implants by Neodent's Drive CM devices.
The Wall Street Journal reports that Endo Health is looking to divest its troubled American Medical Systems subsidiary just 3 years after buying it.
Florida-based diabetes devices maker Nipro Diagnostics lands FDA clearance for 2 new blood glucose monitors and boosts its manufacturing capabilities ahead of a Q4 2014 launch.
Diabetes company Nipro Diagnostics touted FDA wins for a pair of new blood glucose monitors for use in home and professional settings, saying that the device maker will look to boost its manufacturing capabilities ahead of a late 2014 launch.
Nipro Diagnostics, Inc. announces FDA clearance of its newest blood glucose monitoring systems, True Metrix and True Metrix Pro, and expansion of manufacturing in the USA
FORT LAUDERDALE, Fla. – Nipro Diagnostics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has cleared its True Metrix Self-Monitoring blood glucose system and the True Metrix Pro Professional Monitoring blood glucose system.
