News

GE Healthcare will supply cancer Dx tools in new Indian care clinics

GE Healthcare is going beyond just selling diagnostic imaging products in India to get involved, in part, in the distribution of care. The company will team up with a U.S. cancer healthcare operator to open cancer clinics that will rely on some of its key technology.

Intuitive now faces a pension plan's lawsuit over its robotic surgical device

Intuitive Surgical is facing legal pushback from shareholders who claim that the company underreported adverse events and concealed recalls from the FDA related to its robotic surgical device, MassDevice reported.

Chembio got EU approval for its 20-minute HIV test

Chembio announced Tuesday it has received approval to begin marketing its rapid point-of-care HIV test, the HIV 1/2 Stat-Pak Assay, in Europe.

Ariosa Diagnostics close to pulling trigger for IPO worth up to $69M

Ariosa Diagnostics filed plans for an IPO worth as much as $69 million that it will use to heighten commercialization efforts for its Harmony prenatal genetic test.

LabCorp is bringing on a new CFO at a crucial time

LabCorp is bringing on a new chief financial officer, a key position for the diagnostics and genomic testing outfit as it seeks to recharge sales, emerge from a restructuring and combat ongoing insurance reimbursement challenges.

GE rolls out a discount cancer imaging system for personalized medicine in India

GE Healthcare has developed a discount molecular imaging system for cancer detection, intended for physicians practicing personalized medicine in emerging markets--especially India, where the devicemaker got help designing the system.

FDA cites DexCom for glucose monitoring system medical device reporting violations

DexCom, a maker of continuous glucose monitoring systems, got slapped with an FDA warning letter for falling short in its medical device reporting procedures.

NeuroPace's neurostimulation epilepsy implant is already making an impact

As interest in NeuroPace's new RNS neuromodulation antiepilepsy implant ramps up, The New York Times tracked down some of the patients who use the device and have experienced major improvements in their quality of life.

Stryker finalizes $120M deal to snatch up a surgical sponge outfit

Hot on the trail of new M&A deals, Stryker finalized its acquisition of Patient Safety Technologies. The Kalamazoo, MI-based company paid $120 million for the medical device outfit, gaining access to Patient Safety's line of trackable surgical tools.

California startup draws in a $32.6M Series A to advance its neuromodulation implant tech

Axonics Modulation Technologies got itself a $32.6 million Series A funding round that will help advance its implantable neuromodulation technology into human clinical studies to treat a variety of conditions.

Sequenom resolved a long-standing legal dispute with an ex-CFO

Sequenom said it has settled a long-standing lawsuit filed by its ex-CFO alleging defamation in connection with an R&D scandal.

Quest wins U.S. nod for rapid Dx test that helps identify encephalitis

Quest Diagnostics has gained expedited U.S. clearance for a new rapid test designed to help diagnose encephalitis.

St. Jude aims to jump-start the cardiac device space with new pacers and defibrillator leads

St. Jude Medical is confronting a flat pacemaker market and continued fallout from faulty defibrillator leads with a rollout of new products in both spaces. The hope: Next-generation improvements will spur new market interest and greater revenue.

Myriad has a cancer companion diagnostic for Tesaro's PARP inhibitor

Oncology biotech Tesaro will use a cancer test developed by Myriad Genetics to look for tumor types that may respond to PARP inhibitors like niraparib, a Phase III candidate in ovarian cancer and breast cancer, in-licensed from Merck in 2012.

GE finalizes $1B Thermo Fisher Scientific deal, snatches up 3 business units

GE Healthcare completed its acquisition of three Thermo Fisher Scientific units. The $1.1 billion deal gives GE access to Thermo Fisher's profitable cell culture, gene modulation and magnetic bead businesses, helping the company expand its presence in protein analysis and medical diagnostics.

The top companies in med tech: 2013 revenue results

In 2013, a number of outside forces hammered the med tech industry. While things could have been better, most of the top 10 companies in the sector still enjoyed moderate year-over-year revenue gains.

South Korea targets medical device industry as its latest growth engine

Business Korea reported that the government has a goal for its med tech industry to export more than $12.5 billion worth of goods, hire 130,000 people and have a 3.8% global market share by 2020.

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.