The launch of finger pulse oximeter Rainbow has proved disappointing thus far for Masimo. But it's hoping that a new device, MightySat Rx Pulse Oximeter, which just received a CE mark, will fare better. It's a wireless fingertip pulse oximeter that is compatible with smartphones and tablets, enabling physicians to track up to 12 hours of data remotely via these smart devices.
Sens. Richard Burr (R-NC) and Al Franken (D-MN) recently introduced legislation that encourages the FDA to review medical devices in the "least burdensome" manner, as required under the FDA Modernization Act of 1997.
Medtronic reports early pivotal data for tiny leadless pacemaker with U.S. launch slated in a year or so
Cardiac Rhythm & Heart Failure is one of Medtronic's faster growing businesses, driven in part by the launch of tiny subcutaneous heart monitor Reveal Linq. The medical device giant expects that the launch of supersmall leadless pacemaker Micra Transcatheter Pacing System could help it to keep that revenue growth momentum going.
Foundation Medicine is teaming up with healthcare technology firm IMS Health to develop a new cancer diagnostics tool, deepening the company's dive into cancer R&D a few months after it finalized its $1.2 billion deal with Roche.
Medtronic continued its shopping spree, acquiring Aptus Endosystems for $110 million to get its hands on aortic aneurysm repair technology. The June 19 move comes one day after it obtained the rights to acquire another aortic aneurysm player, as well as cardiology company CardioInsight for $93 million. So that's three transactions over two days for the medical device behemoth.
Despite being dismissed by most cardiac surgeons when the idea was put forth 20 years ago, TAVR procedures appear to be catching on in the U.S. for high-risk patients and, possibly in the future, for lower-risk patients as well, The New York Times reports.
The FDA approved a device that enables blind users to interpret the shape, size, location and motion of objects from patterns of electrical stimulation on the surface of their tongue.
Study: At-home hemodialysis more effective than peritoneal dialysis as more options come to the fore
Peritoneal dialysis is the most common kind of at-home dialysis, given its relative convenience and ease of use compared to hemodialysis. But now, in the largest study of its kind, a massive 5-year analysis of registry data in Australia and New Zealand for more than 11,000 patients, researchers have found that patient survival rates are significantly higher with home hemodialysis than with peritoneal dialysis.
The House of Representatives passed a repeal of the medical device tax by a veto-proof margin of 280-140, sending the bill to the Senate.
Undisputed medical device heavyweight Medtronic has been busily wheeling and dealing with tiny startups this year--perhaps putting to rest industry concern that the merger with Covidien would put a damper on strategic backing for private med tech companies as a key player was eliminated.
The FDA released an overview of its considerations and process for reviewing so-called investigational device exemptions, which give researchers permission to test developmental devices on humans.
China is a hotbed of med tech growth, with local companies competing against foreign devicemakers for their cut of the profits. One Chinese company got a boost in the race, as the World Health Organization (WHO) approved Wuhu SNNDA Medical Treatment Appliance Technology's circumcision device for HIV prevention.
The FDA warned of higher mortality rates among patients on SynCardia Systems' Total Artificial Heart Companion 2 Driver System who underwent certain preimplant interventions.
The FDA has approved the Misago Peripheral Stent System from Terumo to treat peripheral artery disease by restoring blood flow to the leg. Upon the FDA's disclosure Terumo almost immediately said it would launch the device at the ongoing Society for Vascular Surgery Annual Meeting in Chicago, IL.
Investors can't get enough of FitBit on its first day of trading on the New York Stock Exchange.
Edwards Lifesciences' Sapien 3 Valve for patients too frail for open heart surgery received FDA approval Wednesday afternoon months ahead of expectations, sending the stock up more than 4%, as investors bet on quick adoption of the latest iteration of the TAVR device.
XIO Group will buy Israeli medical laser player Lumenis for about $510 million in cash. That price tag isn't much of a premium to the company's valuation because a rumor that it would be acquired for about $500 million by China's Fosun Pharma already pushed shares up earlier this year.
Medtronic has invested in a subsidiary of Arsenal Medical, a startup focused on developing a polymer-based foam to control intra-abdominal bleeding. The device giant gains an option to acquire the subsidiary, Arsenal AAA, upon the achievement of undisclosed milestones. Medtronic also didn't reveal how much it invested in the deal.
Cerapedic's i-Factor Peptide Enhanced Bone Graft is likely to hit the market sooner than expected, for the company just announced that an advisory committee meeting will not be required as part of its PMA application for commercialization of high-risk devices.
Abiomed is beefing up operations, building out its headquarters and hiring new employees to accommodate a growth surge fueled by recent regulatory approval for its heart pump device.