News

FDA approves novel tongue sensor for the blind

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.

House repeals medical device tax by veto-proof margin

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.

Medtronic buys noninvasive 3-D cardiac mapping startup CardioInsight for $100M+

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.

FDA hints it will show 'additional flexibility' when it comes to approving device clinical trials

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.

Chinese med tech gets the WHO's OK for circumcision device

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.

FDA issues safety warning to cardiologists based on troubling post-market data

The FDA warned of higher mortality rates among patients on SynCardia Systems' Total Artificial Heart Companion 2 Driver System who underwent certain preimplant interventions.

Self-expanding peripheral stent from Terumo launches just after PMA approval

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.

FitBit up 50% on early trading following $732M IPO

Investors can't get enough of FitBit on its first day of trading on the New York Stock Exchange.

Edwards wins FDA approval for third-gen Sapien TAVR ahead of schedule

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.

After 2014 IPO and recent takeover rumor, medical laser player Lumenis to be acquired for $510M

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 buys into Arsenal, gets option to purchase the post-surgical foam startup subsidiary

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.

FDA moves to decide on Cerapedic's bone graft PMA faster than anticipated

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 builds out headquarters and adds jobs amid growth

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.

Connecticut company wins grant to deploy stem cells for organ regeneration

MultiClonal Therapeutics has been awarded a $750,000 grant to develop personalized therapies for chronic lung diseases like COPD.

GE Healthcare launches radiation dose tracking system for its CT systems

The concern that cumulative radiation exposure over a lifetime of healthcare-related imaging could boost the risk of cancer is addressed in the latest launch from GE Healthcare. It's rolled out DoseWatch Explore to track practice-level radiation dose data from its computed tomography (CT) systems.

J&J sets sail toward Ireland with €153M device manufacturing expansion

Johnson & Johnson is expanding its medical device manufacturing in Ireland, sinking €100 million ($112 million) into its site in Limerick and opening a €53 million ($59 million) plant in Cork as it looks to chart some upward momentum for its lagging device business.

Singapore's Temasek leads $40M financing for sleep monitoring startup Hello

Singapore's state investment company just led an ongoing $40 million financing round supporting Hello, maker of the Sense sleep monitor, demonstrating growing interest in health and fitness-related gadgets among investors, if not the general public.

With $2B acquisition of Welch Allyn, Hill-Rom to add diagnostics, patient monitoring

Medical products company Hill-Rom is using its $2 billion acquisition of patient monitoring and diagnostics player Welch Allyn to decrease its reliance on sales of large, acute-care capital equipment--which are highly subject to pressure from macroeconomic changes. 

Irish startup Neuravi raises $21M to get stroke stent retrieval device through pivotal trial

The biopharma industry has worked for decades to find an effective treatment for acute ischemic stroke with minimal success. At least 5 clinical trials over a recent 6-month period have now found that removing clots using a class of devices known as stent retrievers is an effective treatment for stroke.