News

Gauss Surgical raises $12.6M to accelerate commercialization of its iPad-based blood loss monitor

Silicon Valley's Gauss Surgical, the maker of an FDA-cleared iPad app for quantifying blood loss during surgery, announced the completion of a $12.6 million Series B round, raising its total fundraising haul to $24.6 million. The round was led by Seattle's Providence Ventures. Chicago VC Jump Capital also participated.

Philips enrolls 5,000+ in 3 trials of Volcano's blood pressure measurement technology

Philips' Volcano has enrolled more than 5,000 patients to participate in three prospective clinical studies to evaluate the safety of deferring cardiovascular interventions using measurements from the company's iFR (instant wave-Free Ratio) pressure measurement tech.

Cardiovascular Systems to trim 8% of its workforce in effort to return to profit

Cardiovascular Systems, a St. Paul, MN-based devicemaker, said it will trim about 8% of its workforce as part of the company's efforts to balance cash flow and return to profitability.

FDA gives Medtronic's PillCam OK for expanded indication on major risk patients

The FDA has cleared Medtronic's PillCam COLON 2 ingestible capsule for an expanded indication in patients who are at major risks for colonoscopy or moderate sedation.

Spotlight On... MGH to study Philips' digital pathology tools to get diagnostic clearance; Cook Medical catheter recall deemed Class I; and more...

Royal Philips ($PHG) announced that Massachusetts General Hospital will study the reproducibility of its digital pathology whole slide imaging (WSI) IntelliSite Solution to get to clearance to use...

MGH to study Philips' digital pathology tools to get diagnostic clearance

Royal Philips announced Massachusetts General Hospital will study the reproducibility of its digital pathology whole slide imaging IntelliSite Solution to get to clearance to use the device for primary diagnostic use.

Cautious Stryker pushes launch of total knee replacement on its Mako robot to 2017

Stryker purchased Mako Surgical for $1.65 billion in 2013, with an eye on performing total knee replacement the company's Mako Rio robot-assisted surgery system. Three years later, that has yet to occur despite approval to do so in August 2015.

Swiss team designs robotic exoskeleton that mimics human knee stability

While a robotic exoskeleton to help paraplegics walk is hardly a new concept, mechanical engineers from ETH Zurich have designed one with a knee that mimics the variable stiffness of the human knee so that it can adapt to uneven terrain.

Medtronic launches new device to help treat overactive bladder

Medtronic unveiled a new device for the treatment of overactive bladder that uses an acupuncture-like needle placed under the skin near the ankle to generate gentle electrical pulses, reducing instances of urinary urgency.

Qiagen to pony up $100M+ for Danish molecular diagnostics outfit Exiqon

Diagnostics giant Qiagen will make a bid to acquire Vedbaek, Denmark-based Exiqon for about 683 million Danish kroner ($103.5 million), the company announced Tuesday. The Danish company specializes in molecular diagnostics and life science research tools.

EarlySense launches patient monitoring tech to detect sepsis in non-ICU patients

Waltham, MA's EarlySense has added a new feature to its contact-free continuous patient monitors. It says the Multi-Parameter Alert capability monitors patient heart and respiratory rate to spot changes that could be a sign of an adverse event during hospital stays, such as sepsis, which is often deadly if not detected early.

CMS Joint Replacement Model won't cut implant prices, will reform postprocedural care

Orthopedic companies and hospitals are barreling toward the April 1 implementation of the federal Comprehensive Care for Joint Replacement Model, a seminal CMS pay-for-performance payment policy designed to lower the 90-day cost of hip and knee and surgery. A quarter of the Medicare population in 67 population centers is served by the 1,800 hospitals subject to the mandatory policy.

Philips debuts system to plan prostate cancer radiation treatment using MRI imaging only

Royal Philips today rolled out the first commercially available magnetic resonance (MR)-only solution in the U.S. for use in planning radiation treatments for prostate cancer.

Rythm raises $4M to commercialize its wearable sleep device and associated app

Rythm, the developer of a connected headband designed to improve sleep, got a $4 million infusion of funding from private investors, boosting its total funding to $11 million.

FDA orders consumers to halt using OxySure Therapeutics' emergency oxygen system

Back in June 2015, OxySure Therapeutics recalled replacement cartridges for its OxySure Portable Emergency Oxygen System, Model 615. But the FDA determined the action was ineffective and put out a safety alert Tuesday calling for consumers, healthcare providers, businesses and schools to immediately stop using the device.

CMS policy driving consensus around moderate use of Boston Scientific's Watchman: Survey

A survey by BMO Capital Markets found that most physicians are abiding by CMS' National Coverage Decision when it comes to implantation of Boston Scientific's Watchman implant to prevent stroke by closing the heart's left atrial appendage.

China FDA releases long-awaited med tech clinical trial guidelines

The China FDA unveiled long-awaited medical device clinical trial guidelines. They should provide some clarity to devicemakers, who wish they didn't have to conduct them at all, due to similar arguably duplicative requirements in Europe, the U.S. and Japan.

Intuitive touts study finding Da Vinci robot results in downstream cost savings due to superior outcomes

Intuitive Surgical touted a study published in the journal Value in Health, which found that robotic prostate cancer surgery resulted in savings to payers and society of more than $1,000 per procedure over three years due to more favorable clinical outcomes.

Theranos slammed again after new study points to testing flaws

Theranos' blood tests turned up irregular results more often than products from rivals Quest Diagnostics and LabCorp, researchers found in the first published independent study of Theranos' tests.

Affymetrix spurns bid by former execs in favor of $1.3B offer from Thermo Fisher

Affymetrix, a maker of advanced genetic analysis technology, has rejected an unsolicited bid by former executives in favor of the $1.3 billion offer it received from Thermo Fisher Scientific earlier this year.