Registrar Corp's U.S. FDA News blog provides regulatory updates for FDA regulated industries. Registrar Corp helps medical device establishments comply with FDA regulations, such as registration, listing, UDI and GUDID requirements, 510(k) requirements, and more.
By David Lennarz, Vice President and Co-Founder of Registrar Corp
Here's a look at some of the top regulatory stories for medical device companies this week: Stryker launches Mako robotic hip replacement; Abiomed soars to new all-time high on FDA nod; FDA grants humanitarian use device status to fetal micro-pacemaker; Wright Medical wins FDA nod for Salvation external fixation device; FDA clears Stryker's Lite lumbar plating system
China looks to double the number of its general doctors by 2020 in a bid to improve healthcare in the People's Republic.
(Reuters) — China will almost double the number of its general doctors by 2020, trim its public sector and improve technology as it seeks to fix a healthcare system plagued by snarling queues and poor rural services, its main administrative authority has said.
SynCardia says the FDA approved a clinical trial of its artificial heart as a bridge to transplant for patients with heart failure.
SynCardia Systems said today that it won FDA approval for a clinical trial of its artificial heart as a bridge to transplant for patients with heart failure.
Insulet lures former Analogic CFO Michael Levitz to be its new finance chief.
Royal Philips deals an 80% stake in its lighting components business to Go Scale Capital for $nearly $3 billion.
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 Tom Ulrich
The FDA approves the use of Medtronic's CoreValve transcatheter aortic valve implant in so-called 'valve-in-valve' replacement procedures.
Saphena Medical, which is developing a device to harvest veins for coronary artery bypass grafting, is almost halfway toward raising $3 million in new funding.
Stealthy Saphena Medical reported raising close to half of a $3 million planned offering toward development of a device designed to harvest veins for coronary artery bypass grafting.
The West Bridgewater, Mass.-based startup disclosed in a recent SEC filing that it has pulled in nearly $1.27 million so far, through the sale of Series B preferred stock.
The shareholders of both Uroplasty and Vision-Sciences approve their pending million merger.
InVivo Therapeutics adds the 4th site to a feasibility study of its biodegradable implant to treat acute spinal cord injuries.
InVivo Therapeutics adds the 4th site to a feasibility study of its biodegradable implant to treat acute spinal cord injuries.
Bioness says 4 patients were successfully implanted with its StimRouter neuromodulation device to treat their overactive bladders.
Bioness last week said it's making progress with a Canadian study of its StimRouter neuromodulation device designed to expand the number of conditions for which it can be used for treatment.
Hansen Medical says it inked an exclusive distribution deal in China for its Magellan robot-assisted surgery platform.
The Centers for Disease Control & Prevention are hoping a program piloted in Chicago will help halve the incidence of 'nightmare' infections by so-called antibiotic-resistant 'superbugs.'
(Reuters) — With painstaking effort, a group of Chicago hospitals has managed to cut by half the number of infections caused by an especially deadly type of superbug. Now U.S. health officials want that kind of campaign to go national.
Techniques and products learned by emergency personnel on the battlefields of Iraq and Afghanistan are changing emergency medicine back in the U.S.
(Reuters) — Paramedic Dean Elliott rummaged through the ambulance's emergency kit and pulled out a pint-sized red power drill, a tool whose use was honed on the battlefields of Iraq and Afghanistan.
An insurance company asked a federal judge to declare that they don't have to cover Biotronik's $28 million in losses from a pair of lawsuits filed over the implantation of allegedly unnecessary pacemakers.
An insurance company that issued policies to Biotronik wants a federal judge in Oregon to declare that they don't have to cover Biotronik's losses in a pair of lawsuits filed over allegedly unneeded pacemaker implantations.
The FDA green-lights Brainlab's mobile version of the TraumaCad surgical planning software for hip replacement procedures.
Brainlab said it won FDA clearance for a mobile version of its TraumaCad surgical planning software for hip replacement procedures.
The product, TraumaCad Mobile, will be marketed by Brainlab's Voyant Health unit. The application is compatible with Mac and PC web browsers plus iOS mobile devices.
Departing FDA commissioner Dr. Margaret Hamburg defends the agency's approvals process in her final speech on the job.
(Reuters) — In her final speech after 6 years as commissioner of the FDA, Dr. Margaret Hamburg defended the agency's approval standards against critics seeking weaker regulatory standards.
Anti-trust regulators in the European Union approve the pending, $13.4 billion merger of orthopedic giants Zimmer Holdings and Biomet.
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.
Olympus says it agreed to pay $92 million to settle a pair of civil lawsuits brought over the 2001 accounting scandal that nearly brought the company down.
Armed with a recent $30 million funding found, Obalon Therapeutics launches a pivotal trial for its ingestible weight loss balloon.
California's Obalon Therapeutics said it launched a pivotal trial set for as many as 15 sites across the U.S. that will test its ingestible, gas-filled weight-loss balloon.
The FDA grants a humanitarian device exemption for a micro-pacemaker designed to be implanted in a fetus.
Comparative sizes of fetal
and adult pacemakers.
Click image to enlarge.
Researchers at Children's Hospital Los Angeles and the University of Southern California said the FDA granted a humanitarian device exemption for the fetal micro-pacemaker they designed.
Stryker launches the Bio4 bone-allograft product made by Osiris Therapeutics at the recent American Academy Of Orthopaedic Surgeons meeting in Las Vegas.
The U.S. Senate delays a vote on the so-called 'doc fix' bill to change the way Medicare pays doctors, which passed the House earlier this week.
(Reuters) — The U.S. Senate will wait more than 2 weeks before acting on a bill to permanently fix the flawed formula for reimbursing Medicare physicians, after an April 1 deadline to start a 21% cut in payment rates.
Here's a look at some of the top legal news stories for medical device companies this week: Osprey Medical fishes up $11m private placement; OrthoSensor closes $19m Series C round; Diabetes: Medtronic joins $44m round for Semma Therapeutics
Manny Villafana, who founded St. Jude Medical and Kips Bay Medical, joins a last-gasp, $3 million funding round for Kips Bay.
ReWalk Robotics plans to launch its wearable robotic exoskeleton device in India by the 2nd quarter.
(Reuters) — ReWalk Robotics (NSDQ:RWLK) plans to launch its wearable robotic exoskeleton in India by the 2nd quarter, CEO Larry Jasinski said.
Royal Philips wins another year on its $77 million contract with the U.S. Defense Dept. for patient monitoring equipment made by its Philips Medical Systems division.
Royal Philips (NYSE:PHG) won another year on its contract with the U.S. Defense Dept. for patient monitoring devices made by its Philips Medical Systems division, the Pentagon said yesterday.
President Barack Obama's administration today is set to release a sweeping report on its plan to drastically reduce death rates from antiobiotic-resistant 'superbugs.'
(Reuters) - The White House is due to issue an ambitious plan to slow the growing and deadly problem of antibiotic resistance over the next 5 years, 1 that requires massive investments and policy changes from a broad array of U.S. government health agencies, according to a copy of the report reviewed by Reuters.
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.
Stryker has the FDA's 510(k) clearance for a new spinal repair device, the Lite plate system for lumbar fusion procedures.
Stryker (NYSE:SYK) added another product to its spine division, following a new 510(k) clearance from the FDA.
The U.S. House of Representatives approves a bipartisan 'doc fix' measure that would repair the way Medicare reimburses doctors.
(Reuters) — The U.S. House of Representatives today overwhelmingly approved a bill to permanently repair the formula for reimbursing Medicare physicians, marking a rare bipartisan achievement and sending the issue next to the Senate.
Olympus issues an urgent safety advisory on cleaning the endoscopes implicated in lethal 'superbug' outbreaks across the country.
2014 was the year of the mega-merger, with $40 billion worth of acquisitions - nearly double 2013 and not even including Medtronic's $50 billion Covidien buy - according to EP Vantage.
Source: EP Vantage.
Click image to enlarge.
The $40 billion worth of mergers and acquisitions last year in the medical device industry made it the year of the mega-merger, according to EP Vantage, with deal value more than doubling compared with 2013.
InVivo Therapeutics adds a 3rd clinical site to a feasibility study of its biodegradable implant to treat acute spinal cord injuries.
Here's a look at some of the top Wall Street stories for medical device companies this week: Boston Scientific's gain is St. Jude Medical's loss; Abiomed soars to new all-time high on FDA nod; Philips mulls 2016 IPO for lighting biz as bidding war heats up; SteadyMed prices $40m IPO well under range; Becton Dickinson to shed assets after CareFusion buy
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 former associate professor at New York University, Yudong Zhu, reaches a plea deal on charges that he accepted bribes from a Chinese medical imaging company in return for details of his research.
(Reuters) — A former New York University associate professor has reached a plea deal ahead of a trial on charges that he conspired to receive bribes from a Chinese medical imaging company in exchange for information about his federally funded research.
Wright Medical gains 510(k) clearance from the FDA for its Salvation external fixation device for foot and ankle surgeries.
Stryker launches a total hop arthroplasty application for its Mako robot-assisted surgery system at the American Academy of Orthopedics conference.
Stryker (NYSE:SYK) today said it's launching a total hip replacement tool for its Mako robot-assisted surgery platform.
Medtronic gets in on a $44 million Series A round for Semma Therapeutics, which is developing a cell therapy-device treatment for Type 1 diabetes.
Boston Scientific touts the 1st commercial implantations of its Watchman anti-stroke heart implant.
Becton Dickinson is reportedly planning to shed its respiratory devices business now that it's closed its $12.4 billion acquisition of CareFusion.
Anti-trust regulators in Japan approve the pending, $13 billion merger of orthopedics giants Zimmer Holdings and Biomet.
Sen. Ed Markey (D-Mass.) introduces a new bill to repeal the medical device tax that would cover the estimated $29 billion lost tax revenue by eliminating tax loopholes for oil and gas companies.
The junior senator from Massachusetts, Sen. Ed Markey (D.-Mass), wants to eliminate the medical device tax and replace the lost revenue by eliminating tax loopholes for the energy industry.
Surgical Specialties plans to shutter a plant in Reading, Pa., meaning layoffs for about 254 workers.
Surgical instruments maker Surgical Specialties is planning to permanently shutter a plant in its hometown of Reading, Pa., this spring, meaning layoffs for roughly 254 workers.
Rep. John Boehner says the prospects are good for a permanent 'doc fix' to prevent a 21% cut in the Medicare rates paid to doctors.
(Reuters) — U.S. House of Representatives Speaker John Boehner (R-Ohio) said today that prospects are good for passage of a permanent fix to Medicare's flawed doctor-pay formula that would spare physicians from impending steep pay cuts.
