News

Swiss researchers develop bendable implant to tap into the spinal cord

Swiss researchers have come up with a soft and flexible implant that has the same ability to bend and stretch as the membrane that wraps around the human brain and spinal cord, and could lead to helping people with paraplegia to walk again.

Leerink equity analysts bullish about Boston Scientific

Leerink equity analysts upgraded shares of Boston Scientific today to the "outperform" rating from the "market perform" rating, citing new product launches and manageable litigation risk.

FDA approves first blood screening test to detect HIV, HCV and HBV from Roche

The FDA has approved a triple test from Roche to simultaneously detect HIV, hepatitis C and hepatitis B in donated blood and blood products. It's the first test approved by the agency to simultaneously test for all three of these blood-borne diseases and is expected to reduce the necessary sample volume and the testing turnaround time.

In a win for Spectranetics, Covidien's to-be-divested drug-coated balloon earns CE mark

Covidien today announced the CE mark granted for its Stellarex drug-coated balloon for peripheral artery disease. In addition to physically displacing the lesion with angiopolasty, Stellarex delivers the drug paclitaxel like many of its European competitors.

FDA says Expedited Access PMA, new LDT regulations, will be implemented this year

The FDA promised to finalize an expedited approval pathway for medical devices that address critical unmet needs and to officially expand its authority into the regulation of lab-developed molecular diagnostic tests in its annual list of upcoming medical device-related guidance documents for the new year.

PureTech bumps its early life science funds up to $107M

Not quite a venture firm, research institute or startup, PureTech is a bit of all three. The mission of the early stage research company just got a little bit easier--it bumped up its recent fundraising to $107 million from the $57 million it had raised as of October.

C.R. Bard pushes for delay of vaginal mesh trial after judge's call for settlement

Weeks after a federal judge encouraged C.R. Bard to resolve thousands of pending lawsuits over its vaginal mesh implants, the company is requesting a delay of its product liability trial, arguing that the judge's comments regarding a potential settlement may have prejudiced the jury pool.

Two new healthcare VC funds with $225M to spare are on the horizon

Boston's HLM Venture Partners is raising $150 million to create a fourth fund. In addition, Connecticut's HealthInvest Equity Partners has created a $75 million fund, focusing on healthcare.

Philips receives FDA clearance for cableless fetal monitor

Philips announced FDA clearance of its Avalon CL Fetal Monitoring solution to monitor pregnant women without the use of cables, enabling more freedom of movement during labor.

CardioFocus raises $32M, partners in Japan ahead of pivotal atrial fib data

CardioFocus may be gearing up to file a PMA for its HeartLight catheter ablation system. Since the start of the New Year, the company has disclosed that it raised $32 million in a new financing and partnered with Japan Lifeline in an exclusive, multi-year Japan distribution agreement for HeartLight.

FDA lifts import restriction on Hospira as it aims to reinvigorate its infusion pumps

Hospira vowed to cut old product lines, address its production problems and invigorate innovation in its medical devices business as part of a grand plan revealed on May 1, 2013. Now it's making some progress as it said FDA had lifted an import alert that had prohibited import of infusion pump devices manufactured in its Costa Rica plant.

23andMe's $60M deal with Genentech shows an alternative path forward for diagnostics companies

Consumer-oriented genetic testing company 23andMe's up to $60 million partnership to provide Big Pharma company Genentech with access to information on about 3,000 Parkinson's patients illustrates the value of diagnostic companies' genetic information.

Sera Prognostics rakes in $20M in Series B round for preterm birth prediction test

Sera Prognostics roped in $20 million in Series B financing to develop its test for preterm birth prediction, giving the company a boost as it competes for a place in a crowded prenatal diagnostics market.

Washington Post issues its verdict on job losses from the medical device tax

In a sign that the medical device tax is becoming, or has become, not just a device industry issue but a national one with political prominence, the Washington Post subjected the common claim that the medical device tax has eliminated thousands of jobs to its political fact checker.

Study: BrainScope's investigational device shows promise in stroke diagnosis

A study of 183 patients the journal Academic Emergency Medicine found an investigational non-radiation emitting, handheld device developed by BrainScope to be a valuable adjunct to standard CT and MRI scans in the diagnosis of stroke.

Cerus uses momentum from recent FDA approvals to raise $70M

Cerus is up almost 40% in the last month on news of a couple of approvals for its Intercept Blood System to treat blood products. The small cap took advantage of that upswing to raise $70 million to help finance commercialization of the system.

Alere snags first FDA CLIA waiver for molecular influenza test

Alere won an FDA CLIA waiver for its molecular influenza test, giving the company a boost amid restructuring efforts and putting its diagnostic in the hands of more healthcare professionals as flu season reaches epidemic status.

FDA clears pivotal trial for permanent use of artificial heart

SynCardia Systems is aiming to have the first artificial heart approved by the FDA for permanent use. The agency has approved a pivotal trial design to test the startup's Total Artificial Heart as a heart replacement.

Shockwave's energy-delivering angioplasty balloon for PAD receives CE mark

On the heels of the FDA's approval of a second drug-coated balloon for peripheral artery disease, Fremont, CA's Shockwave Medical announced the receipt of a CE mark for its Lithoplasty balloon catheter which delivers lithotripsy, a pulsating form of mechanical energy, prior to performing angioplasty.

New technology can spot cavities early, but is that necessary?

The $14,000 Canary System is a new technology that can detect signs of tooth decay earlier than an X-ray can. It uses lasers to grade teeth on a 100-point scale and can enable earlier intervention. But insurance companies aren't reimbursing the Canary System, fearing overtreatment.