News

St. Jude Medical got hit with another lawsuit over its recalled Riata debrillator leads

St Jude Medical got hammered with a new lawsuit from a Pennsylvania man who claims the company's now-recalled Riata cardiac defibrillator leads injured him. The latest Riata legal fight underscores the reality that fallout from the product's problems won't be going away any time soon.

Navidea inches closer to EU approval for its Lymphoseek Dx imaging agent

Navidea Biopharmaceuticals met with European regulators who hold the key to approving its Lymphoseek injectable diagnostic imaging agent, and the company said it has met the benchmarks it needs to gain market authorization.

BioMérieux is eyeing a Siemens division, among other buy prospects

Not long after digesting its $450 million buyout of BioFire Diagnostics, bioMérieux seems to be on the hunt for another acquisition. Reuters reported recently that the French company is eyeing Siemens' microbiology unit.

Yes, U.S. med tech recalls have doubled since 2003--but so has the market

"Medical device recalls nearly doubled in a decade," proclaims The Wall Street Journal's headline--a bit of data the FDA is expected to release Friday that seems likely to travel far on social media. Critics are already making hay, questioning the rigor of pre-market vetting at the FDA.

Beleaguered Orthofix brings in a new chairman

 Beleaguered Orthofix International is bringing on new chairman of the board. Ronald Matricaria has served executive roles at St. Jude Medical and Eli Lilly, and is currently chairman of the board at Volcano.

Cochlear scores critical FDA approval for its innovative hearing aid system

In a major regulatory win, Cochlear--the world's largest maker of hearing aids--scored FDA approval for its next-generation hearing device to treat sensorineural hearing loss.

St. Jude Medical grabs a CE mark for 'burst' neurostim treatment of chronic pain

St. Jude Medical nailed a CE-mark approval for the company's next-generation neurostimulation device to treat chronic pain. The European regulatory win allows it to hit the market overseas with its Prodigy system even as it ramps up for U.S. clinical trials of the novel product.

Qiagen hits the Chinese market with a next-gen TB test

Qiagen has started marketing a next-generation tuberculosis blood test in China, four months after winning regulatory approval there in what will be a key market for the company in the months ahead.

Bacterin 2013 revenues improve slightly; net losses rise significantly

Bacterin International, a maker of bone-graft materials and medical coatings, reported a slight increase in 2013 revenues of $33.1 million compared to $30 million the previous year, though net losses for the year jumped to $12.7 million from $7.7 million in 2012.

Invendo raises $28M for its kinder, gentler colonoscopy

German medical device developer Invendo Medical has closed a round of €20.3 million ($28 million), led by a new investor, Xeraya Capital, to bring to market its single-use colonoscope.

Imaging tech developer NinePoint nails a $34M Series B from Corning, Third Rock and Prospect

Corning is the lead investor in NinePoint Medical's newly nailed-down $34 million Series B round. The 2012 Fierce 15 winner and developer of a cutting-edge organ imaging system also convinced founding investors Third Rock Ventures and Prospect Venture Partners to take part in the company's latest financing.

Senators ask FDA for answers about its regulation of mobile medical apps

The mobile medical app regulation saga continues: Congress sent the FDA a letter this week to inquire about the agency's regulation of the technology and to clarify a few talking points, MobiHealthNews reported.

Barcelona VC outfit is seeking $139M for med tech, Dx and Rx investment fund

Ysios Capital, a major venture capital firm based in Barcelona, is looking for $139 million to seed a new investment fund that will back promising med tech, diagnostics and pharmaceutical companies.

Stryker, slowly but surely, settles 8 more metal hip lawsuits

Stryker, facing over 1,000 lawsuits alleging it sold faulty metal hip implants that hurt patients, has chosen to settle more cases rather than fight them in court.

NEJM publishes results from Exact's pivotal colon cancer Dx study

Exact Sciences is celebrating positive results from a massive pivotal trial of its colorectal cancer diagnostic now published in The New England Journal of Medicine, an important achievement on the long regulatory road to approval.

Flagging Smiths Medical, soaring pound weigh down Smiths Group earnings

A British pound rising against the dollar cut into results at Smiths Group--but its U.S.-based Smiths Medical division, beset by competitors, led the bad-news story in the company's earnings report on the first half of its 2014 fiscal year.

Augmedix grabs $3.2M for Google Glass-enabled medical records physician tool

With Augmedix's new $3.2 million in venture funding, the use of Google Glass for healthcare gets a major boost. The San Francisco startup uses Google Glass technology to help doctors more efficiently push information to most electronic health records systems and also verbally seek information from them, according to the company's website.

C.R. Bard enrolls first patient in a new U.S. clinical trial of its drug-coated balloon

C.R. Bard enrolled its first patient in a new U.S. clinical trial of its drug-coated balloon. The technology could provide an alternative to traditional treatment methods for in-stent restenosis, the company said in a statement.

OrbiMed backs an Israeli startup developing a futuristic, hand-held diagnostic device

Israeli startup Tyto Care is the latest company focused on developing a futuristic hand-held device that enables remote diagnosis for a wide variety of conditions. OrbiMed Israel Partners and early stage investor LionBird are impressed enough with the company's prospects that they led a $4 million Series A funding round.

St. Jude Medical will test its leadless pacemaker in a massive EU postmarketing trial

St. Jude Medical is embarking on a massive postapproval study in Europe for its Nanostim leadless pacemaker, barely weeks after beginning U.S. trials for the same device.