News

Edwards scores victory against Neovasc in transcatheter mitral valve courtroom battle

Edwards Lifesciences' CardiAQ Valve Technologies scored a victory in a courtroom battle with a rival and former service provider that allegedly stole the company's trade secrets to develop its transcatheter mitral valves.

Stanford engineers design portable, at-home urine test to detect various diseases

Urine tests are a staple at the doctor's office, but take time, cost money and can pile up quickly. Good news: Stanford University engineers are working on a low-cost, portable version of the test to ease the burden on doctors and clinics.

CMS starts reimbursement analysis process for leadless pacemakers

The Centers for Medicare and Medicaid Services (CMS) has started an analysis for a national coverage determination (NCD) for its coverage of leadless cardiac pacemakers.

FDA approves first standalone 3-D mammography system for Siemens

The use of 3-D mammography to complement a standard 2-D approach in breast cancer screening is becoming more standard. But all previous FDA approvals of mammography systems have included a combination of both 3-D and 2-D approaches. Now, Siemens has nabbed the first FDA approval for a 3-D digital breast tomosynthesis system.

Pfizer's Hospira launches first patient-controlled pain pump integrated into EMR

Despite all the innovation in med tech on so many fronts, it's often a slow process to see those efforts incorporated into patient care in a way that could improve their treatment and aid healthcare providers. Now, Hospira is debuting a device that seems a no-brainer in terms of making routine hospital care more efficient--and potentially safer.

J&J to enter structural heart devices, details Verb strategy in robotic surgery

Johnson & Johnson has pledged annual growth for its medical device business of about 4% to 6% through 2020. To drive that, it's looking to further enhance its fastest growing market segments while getting to market in surgical robotics and entering structural heart devices, the company told investors on May 18.

Theranos trashes two years of blood test results to appease livid health regulators

Theranos is in deep trouble with federal health regulators, and it's pulling out all the stops to get back in their good graces. The company threw out two years of results from its Edison devices, the controversial linchpin behind its proprietary blood testing technology.

Dx Digest: Foundation Medicine wages patent battle against Guardant Health; 10x Genomics launches new sequencing system

In this week's Dx Digest, Foundation Medicine got a patent for its cancer genomic sequencing technology and is using that patent to sue one of its rivals in the liquid biopsy market, Becton Dickinson scored European approval for its test for vaginal bacterial infections, and 10x Genomics released a new system for long-range genomic profiling.

SF accelerator Highway1 debuts startups with continuous blood pressure monitor, incontinence smart patch

Hardware tech accelerator Highway1 is debuting its sixth class of startups, which includes Blumio, with its cuffless continuous blood pressure monitor, and Sensassure, with its incontinence patch that alerts caregivers when seniors need pads changed.

JAMA: Helmet-based treatment better than face mask for respiratory distress

A transparent, airtight helmet is better than intubation to provide breathing support to patients with acute respiratory distress syndrome, a study published in the Journal of the American Medical Association has found.

Medtronic buys into power morcellators in $350M purchase from Smith & Nephew

Medtronic is buying up the gynecology business from Smith & Nephew for about $350 million. The move is particularly interesting since the purchase is focused on the Truclear power morcellation system.

Allurion raises $6M to back ingestible weight-loss balloon; pivotal U.S. trials may start in 2017

The market for intragastric balloons to enable weight loss is just getting started in the U.S. after a pair of FDA approvals last summer for the first devices in this category--although it's been in full swing in Europe for years. The FDA-approved options are placed and removed endoscopically--but the newest iteration is an ingestible device that is filled with liquid after it's ingested into the stomach.

Medtronic enters robotic spinal surgery in a partnership with, investment in Israeli small cap

Medtronic has made its long-awaited entrance into robotic surgery in a deal with small cap Israeli player Mazor Robotics. The investment will likely be for more than $50 million and will come in three potential tranches. It will result in Medtronic owning about 15% of Mazor, if all the tranches are executed.

Genomic test prep company Purigen reels in $18.2M in Roche-led Series A round

Genomic test prep company Purigen Biosystems reeled in $18.2 million in a Series A round to support development of its benchtop testing technology.

Edwards aims to go younger in 2017 with bioprosthetic aortic valve: Study

Edwards Lifesciences expects to launch a new bioprosthetic valve next year. Management has already described its Inspiris as a "game changer" that could be useful for a younger patient population.

Axion raises $6M to recreate brain activity, heartbeats on the benchtop

Axion Biosystems has raised $6 million to back its Maestro multiwell microelectrode array platform, a high-throughput system for cellular analysis that enables researchers to recreate complex, active systems such as brain activity and heartbeats.

Tricuspid, mitral valve repair startup raises $40M to back regulatory approvals, launch

Mitralign has raised $39.8 million in a Series E round to help it get U.S. and EU approvals for its tricuspid valve repair system and to launch its mitral valve repair system in Europe. Transcatheter mitral valve repair and replacement were white-hot areas of strategic investment last year as major med techs worked to anticipate the best follow-up play to the massive success of transcatheter aortic valve replacement.

ReWalk, Wyss Institute team up for lower-limb exoskeleton development

ReWalk Robotics is teaming up with Harvard University's Wyss Institute for Biologically Inspired Engineering to develop a lightweight exoskeleton system for individuals with lower limb disabilities.

J&J and HP partner on 3-D printing for medical, consumer products

Johnson & Johnson is slated to make its case to Wall Street on its Medical Device and Consumer businesses on May 18. The conglomerate has been under pressure from investors to spin out these groups, which are vastly underperforming its Pharmaceutical segment. J&J is bent instead on salvaging them, working to restructure Medical Devices since early this year and aiming to take action on more innovative initiatives.

Luminex to snatch up Nanosphere in $58M all-cash deal

Luminex is shelling out $58 million for Nanosphere to get its hands on the company's rapid molecular microbiology tests and boost its lab presence.