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 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.
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.
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.
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.
Amid growing scrutiny over duodenoscopes' role in spreading potentially lethal bacteria, a California hospital is reporting a suspected superbug outbreak linked to the devices.
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.
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.
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 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.
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.
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.
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.
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'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.
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.
In a bid for regulatory convergence with other international regulators, the FDA announced it is looking for companies to participate in a pilot program involving the use of a common international format for regulatory submissions like 510(k)s and PMAs.
As companies such as Boston Scientific, Johnson & Johnson and C.R. Bard continue to face claims over allegedly defective vaginal mesh devices, new evidence is mounting against an industry that profits off women undergoing surgeries to remove the implants.
The FDA is looking for participants in a pilot program that would involve quarterly reporting medical device malfunctions.
Owlet Baby Care has expanded its Series A round by $6 million. It also picked up another $1 million in a National Institutes of Health grant--to bring its fundraising total to $9.2 million. The startup will use that cash for a fall launch of its Owlet Baby Monitor that is intended to alert parents via smartphone if their baby stops breathing.