News

Report: Device industry on track for most new approvals in a decade

With 26 new devices receiving FDA's stringent PMA approval or Humanitarian Device Exemptions (for those that treat rare diseases) so far this year, the device industry is on track to see its highest number of approvals in a decade.

DARPA-backed Wyss Institute sepsis device being readied for human trials

A device to cleanse circulating blood of pathogens and toxins under development at the Wyss Institute of Harvard University is ready for large animal testing--a precursor to advancing into a human proof-of-concept trial. This is a new iteration of the device that's designed to work with conventional antibiotic therapies in order to offer a more functional design for clinical use.

Stryker recalls 16,000+ orthopedic implants due to poor packaging integrity

Stryker is recalling 16,992 units of 5 orthopedic devices of the arm because their packaging might be compromised during transportation. Specifically, the packaging's sterile barrier might be affected by the problem, according to the FDA's recall database.

FTC settles with a pair of UV disinfectant device makers for false claims

The U.S. Federal Trade Commission (FTC) has settled with two makers of ultraviolet light devices that the agency said made false claims about product efficacy. The devices were marketed to consumers with claims that they could eliminate fungus and dangerous bacteria without providing sufficient supporting evidence, the agency said.

Potential bidders decline to challenge St. Jude's $3.4B bid for Thoratec

The 30-day "go-shop" period for LVAD maker Thoratec is over. No other bids to acquire the company were made. That means Thoratec is likely to become part of St. Jude Medical in the Q4, when the bigwig's $3.4 billion acquisition is expected to close.

Gauss raises $3.3M for real-time surgical blood loss monitoring system, iPad app

Gauss Surgical expects that its real-time blood loss monitoring system could help reduce the perceived need for transfusions--which it says are inappropriately used up to 60% of the time. The startup has raised $3.3 million to support its Triton System that offers a fast, easy assessment of blood loss during surgery.

Patient monitoring company expanding in Milwaukee, adding 150 jobs

Mortara Instrument, a maker of heart monitoring devices, is expanding its manufacturing and distribution operations in Milwaukee, WI. The creation of a 64,000-square-foot facility near its headquarters will create 150 jobs over the next 5 years, the company says.

Silicon Valley startup raises $55M to offer second opinions prior to surgery

San Francisco startup Grand Rounds is offering second opinions to cut down on unnecessary or inappropriate surgeries. It just announced a $55 million VC haul, to take its total to $106 million.

Startup nabs $5.3M to back 2015 launch for connected fertility thermometer, app

Kindara hopes to make conception a bit less fretful for women. It has raised $5.3 million in seed financing for a launch slated for the end of this year of its Wink wireless basal thermometer that connects to a corresponding fertility tracking app. The startup expects the device/app combo will be useful for women both as a tool to ease conception, as well as a means of avoiding it.

Olympus duodenoscopes linked to suspected superbug outbreak at California hospital

Amid growing scrutiny over duodenoscopes' role in spreading potentially lethal bacteria, a California hospital is reporting a suspected superbug outbreak linked to the devices.

Italian court ruling clears way for Sorin's previously disputed merger with Cyberonics

Italy's Sorin Group fended off an objection to its planned merger with Cyberonics brought by the State's Attorney of Milan. Its stock is up almost 6% on the Milan Stock Exchange, as investors celebrate the news that the planned holding company, LivaNova PLC, is on track to be formed in the U.K. as planned thanks to a favorable court ruling.

LDR raises $86.5M to back ongoing launch of cervical disc replacement device

Spinal surgical device player LDR Holding has raised $86.5 million in a follow-on financing on the strength of its revenue growth. The $1.2 billion company expects to see revenue increase by as much as 20% before the currency impact in 2015--but hasn't guided as to when it expects to become profitable.

Devicemakers clamor for Google Glass with product updates on the horizon

Google has faced some stumbling blocks with Google Glass since launching the product in 2013, deciding earlier this year to stop selling the device to consumers in light of waning sales. But the company is set to meet increased demand for the product among devicemakers as a new version of Glass hits the market.  

 

Boston Sci earns FDA approval of Innova stent to treat peripheral artery disease

Boston Scientific announced FDA approval of its Innova Vascular Self-Expanding Stent System for treating peripheral artery disease. The device was approved via the agency's stringent PMA pathway for high-risk, innovative devices.

First commercial weight-loss balloon implanted in U.S. by Mayo Clinic

The FDA recently gave the obese a less invasive form for weight loss by approving two weight-loss balloons: ReShape Medical's Integrated Dual Balloon System and Apollo Endosurgery's Orbera Intragastric Balloon.

PCORI devotes $30M to outcome studies of orthopedic, bariatric and appendix surgery

The federal Patient-Centered Outcomes Research Institute just approved $30 million in funding for comparative outcomes studies related to med tech, as part of the $65 million in research awards the agency doled out to 6 teams.

Moody's ups medical device industry rating to positive amid M&A, new products

The typically conservative credit rating agency Moody's Investors Service has raised its outlook for the U.S. medical products and devices industry to positive from stable. The firm said it expects to see solid earnings growth over the next 12 to 18 months from the industry.

E-cigs take center stage as U.K. advises use as a stop-smoking aid

The regulatory territory around e-cigarettes is murky. It's clouded by scientific issues around the potential and relative harm they cause, as well as governmental concerns around its oversight as a tobacco or a smoking cessation product.

Intarcia diabetes implant bests Merck med, raising hopes for speedy approval

Intarcia's subdermal osmotic pump beat Merck's mega blockbuster diabetes med Januvia in a clinical trial, increasing hopes for the device's FDA approval in 2016, as the med tech sector one-upped its larger pharma counterpart, raising the spirits of device world.

Roche makes another Dx acquisition of genomic reagent player Kapa

Sharpening its edge in diagnostics is core to the revenue growth strategy at Roche. The biopharma's deal activity in the last week is certainly a testament to that. It will acquire Kapa Biosystems, which provides enzyme optimization for next-gen sequencing and PCR.