Soon, transcutaneous electrical nerve stimulation to treat headache will only require a 510(k), the FDA said in a July 3 final order published in the Federal Register.
Israeli cardiovascular device startup Mvalve Technologies has received a $15 million convertible loan from BSC International Holdings, a subsidiary of Boston Scientific. In addition, BSC received an option to acquire Mvalve for $200 million, according to the Israeli business publication Globes.
As Covidien strides into a merger with Medtronic, the company last week announced the appointment of Bill Burke as CFO for Covidien Europe.
The FDA slapped HeartWare International with a formal warning letter one month after citing the company for safety issues related to its HeartWare Ventricular Assist Device system.
Five senate Democrats called for the White House Office of Management and Budget to release a long-sequestered FDA draft guidance on laboratory developed tests for public comment. In a letter to OMB acting director Brian Deese, they urged him to release the proposed regulation "to ensure appropriate and efficient oversight of diagnostic tools can move forward in an open and transparent manner."
Insulin pumps do a better job of helping control glucose levels in people with Type 2 diabetes than multiple daily injections, according to results from a new study funded by medical device maker Medtronic.
An early step for any hospital patient on the mend is often walking from bed to chair. Physicians have long recognized that walking and sitting upright aids in the healing process but this can be complicated given the various leads and attachments necessary for patient monitoring. Now the FDA has cleared the first sensor to monitor heart rate, respiratory and movement monitors in a chair.
The potential nomination of Johnson & Johnson chief intellectual property counsel Philip Johnson as director of the U.S. Patent and Trademark Office suggests efforts to reform the patent system are dying, especially changes to rein in so called patent trolls.
Encision won FDA 510(k) clearance for its next-generation active electrode monitoring (AEM) technology for monopolar laparoscopy procedures.
The FDA buckled down on medical device manufacturers in fiscal year 2013, issuing 217 warning letters for companies to swiftly correct their violations.
Hiring ahead of and cutting after mergers is always tricky, but organizational change marches on. Post-merger Johnson & Johnson and pre-merger Covidien are both forging ahead, with cuts in J&J's DePuy Synthes and hiring for Covidien.
The president of Covidien's $1.6 billion vascular product group said that the impending merger with Medtronic was necessary from her perspective because being "a vascular player without cardiovascular, I think long term that would have been a real issue.
Bellerophon, a spinoff of private-equity backed specialty pharma company Ikaria, has brought in former Amgen heavyweight Jonathan Peacock as chairman and CEO. Peacock said he expects to get three programs into Phase III development within the next 12 to 18 months.
Gold nanoparticles help prevent the formation of antibiotic resistant biofilm on the surface of orthopedic implants, researchers at the Shanghai Institute of Ceramics discovered.
Startup Rotation Medical nabbed a $27.2 million Series B round from a group of high-profile VCs including Life Science Partners and New Enterprise Ventures. It will use the money to finance a July launch and post-market clinical studies of its rotator cuff system that FDA cleared in March.
Intuitive Surgical is kicking off direct sales of its da Vinci Surgical Systems in Japan, continuing its push in emerging markets and hoping to generate positive numbers after a year of sluggish sales.
A strong combo of an Apple iPad and a specially made attachment are working together as a state-of-the-art multiple sclerosis assessment tool.
With more M&A, product development and restructuring on the horizon, med tech CEOs have their work cut out for them in the coming year. But for now, here's the breakdown of what they took home in 2013.
A pair of small-cap medical device companies have raised a total of $56 million in debt. Cerus got a $30 million credit facility from Oxford Finance to fund FDA approval and marketing for its product, while Amedica, which makes spinal and joint implants using silicon nitride, got $26 million in debt.
Canada will follow the International Medical Device Regulators Forum unique device identification guidelines to the "T" as it works toward the national implementation of the tracking system. Mass Device reports that federal regulator Health Canada has no plans to add any Canada-specific guidelines at this time.