News

NIH proposes a large-scale collaborative research effort into nondrug pain management

The National Center for Complementary and Integrative Health at the National Institutes of Health (NIH) has proposed conducting large research studies of nondrug pain management approaches. It did so in a report by a working group of the Center's Advisory Council.

Intraocular lens maker Staar Surgical gets warning letter over its manufacturing practices

Intraocular lens maker Staar Surgical was hit by an FDA warning letter over compliance with Good Manufacturing Practices at its plant in Monrovia, CA. The company says that on Feb. 4 the FDA issued a Form 483 warning letter with 10 observations.

J&J's DePuy Synthes adds to orthopedics strength with arthroscopic visualization startup buy

DePuy Synthes will introduce imaging for minimally invasive arthroscopic surgeries with the purchase of Utah-based startup Olive Medical for an undisclosed amount. Orthopedics is one of its stronger medical device businesses and this Johnson & Johnson company is focused on leveraging its scale across it.

Med tech venture firm BioVentures raising $100M fourth fund

BioVentures Investors has raised almost $20 million of a new $100 million fund, according to a regulatory filing with the SEC. If it's successful, that would almost double its amount under management, which was $133 million in three funds prior to recent fundraising.

Investors set sail toward China's rapidly growing device market

Amid rapid growth in China's medical device sector, investors are looking to cash in on the market with a string of M&A deals.

Welch Allyn partners with Spok to provide mobile alerts for its vital signs monitors

Patient monitoring player Welch Allyn has partnered with software company Spok to connect its vital signs monitors to the mobile devices of healthcare practitioners. The idea of a systemwide connection approach is to better prioritize and not overwhelm staff with device-related alarms.

Third Rock's NinePoint Medical gets $15M in debt for novel imaging

NinePoint Medical has raised $15 million in debt to support the marketing of its endoscopic volumetric imaging system of the esophagus. The financing comes almost two years after the company launched its NvisionVLE Imaging System in the U.S.

Zimmer revises its regulatory submission in bid to get approval of Biomet acquisition

Zimmer revealed that it has submitted a revised package to the European Commission to get approval of its $13 billion purchase of Biomet. The revision makes changes from the package proposed in December based on feedback from the commission. The deadline for the commission's decision is May 26. Zimmer still expects the transaction to close by the end of the current quarter.

Endoscopes linked to spread of deadly drug-resistant bacteria in hospitals

In the latest incidence of the outbreak of infections stemming from unclean endoscopes, 8 patients in Philadelphia were recently infected with bacteria resistant to the antibiotics known as carbapenems, which kill up to half of those infected, the Philadelphia Inquirer reports.

Biosensors Japan's PhIII trial of drug eluting has enrolled patients

The last of 140 patients have been enrolled in a trial of Singapore-based Biosensors International's clinical trial of its drug-coated stent, BioFreedom, according to a news release. The trial is being conducted in Japan by Leaders Free Japan patients at high risk of bleeding.

St. Jude starts study of world's tiniest pediatric mechanical heart valve

St. Jude Medical is starting a trial for a device that it hopes will be the smallest FDA-approved pediatric mechanical heart valve. The device is only 15 mm in diameter; that's roughly equivalent to the length of a staple.

Check out these next-gen devices in the incubator pipeline

Med tech incubator Edison Nation Medical gave FierceMedicalDevices details about the medical devices in its pipeline that are in need of a licensing partner. They range from a simple wand for collecting urine specimens to an asthma inhaler that can be conformed to fit in your wallet.

DARPA targets prostheses that offer sensation; researchers aim to get there in 5 years with $20M

The U.S. Defense Advanced Research Projects Agency (DARPA) has made the creation of upper-limb prosthesis, artificial arms and hands that allow for sensory feedback a top priority--it's backing 8 research organizations to do so.

Ahead of BD deal close, CareFusion partners to sell ventilators, sleep apnea device

CareFusion has made a pair of marketing deals, one to sell a line of ventilation equipment from Breas Medical and the other to distribute a sleep apnea device from Apnea Sciences. The financial terms of both deals remain undisclosed.

Days after permanent injunction, Maquet is whacked with an FDA recall over product it distributes

The woes of German medical device maker Maquet Holding continue. Just days after the Department of Justice slapped it with a permanent injunction due to product safety issues, the FDA rapped its Servo Humidifier 163 with two Class I recalls.

FDA regulatory oversight apparent in failed knee replacement procedure, experts say

As lawmakers and industry groups call for increased regulation of medical devices, experts are pointing to a failed knee replacement surgery to illustrate the FDA's oversight.

FDA clears first stroke stent system to go in via the neck from startup Silk Road

The FDA has cleared the first system to reduce stroke risk that introduces a stent via the neck. The device, the Enroute Transcarotid Neuroprotection System from startup Silk Road, is expected to offer an option for patients whose vasculature is too convoluted to introduce a stent via the femoral artery in the groin.

Meet Eve, a robot that discovers drugs

Researchers at the University of Cambridge say a robot named Eve has discovered that an anticancer compound is a good candidate to combat malaria. 

Make-or-break time for med tech IPOs, as 5 could go this week and SteadyMed files

Three med techs are preparing to make their market debut this week: drug metabolic test maker AltheaDx and cardiovascular plaque imaging and treatment company Infraredx, both of which were initially expected last week, as well as Invitae, AutoGenomics and Bellerophon Therapeutics.

Boston Scientific partners with Bard to distribute Lutonix drug-coated angioplasty balloon in the U.S.

The market for drug-coated angioplasty balloons to treat peripheral artery disease has been bursting with activity in recent months. Boston Scientific joined the parade today, albeit as a distributor.