Scott Gottlieb's nomination as the next FDA commissioner is garnering support from industry, but it's generating some opposition from other quarters. A few lawmakers and Public Citizen, a watchdog group, were among the first to express concern about the nomination, citing Gottlieb's connections to industry and his "deregulatory approach." "Gottlieb is entangled in an unprecedented web of big pharma ties," said Michael Carome, director of Public Citizen's Health Research Group. He noted that Gottlieb – a physician, resident fellow at the American Enterprise Institute, venture partner at New Enterprise Associates and a former FDA official...

Medtronic plc has had a couple of failed trials in below-the-knee peripheral arterial disease (PAD) with its drug-coated balloon (DCB) technology. Now, the Dublin, Ireland-based med-tech giant is giving it another shot with a small, European study using improved technology and clinical trial design. The results, expected in 2020, could offer initial evidence that DCBs can provide enough long-lasting vessel patency to improve wound healing in tough-to-treat patients. Competitor C.R. Bard Inc. is the only company with an ongoing IDE trial for a DCB in arteries below the knee. "We have a lot of history...

Like their biopharmaceutical colleagues, publicly listed medical technology companies have roared out of the gate this year as investors flood back into health care. Companies have benefited from record-breaking market highs being driven by a increased optimism that the U.S. economy is poised to enjoy better times ahead. To track the market progress of the sector, we have created the Medical Devices Index, which will complement the MDD Stock Report. This price weighted index will record and track on a monthly basis the stock price performance of 20 of the leading medical technology companies...

The U.S. federal budget blues are not going anywhere anytime soon, but Sen. Roy Blunt (R-Mo.), chairman of a Senate Appropriations subcommittee, said in a March 8 hearing that Senate appropriators are committed to a $2 billion annual increase in the NIH budget, which would combine with other recent increases to boost NIH funding by more than $44 billion over the coming decade. Blunt chaired the March 8 meeting of the Senate Appropriations subcommittee with jurisdiction over the Department of Health and Human Services, and said the hearing was to "establish our firm commitment to...

Two committees of the House of Representatives have unveiled the much-discussed legislation that would overwrite several vital features of the Affordable Care Act (ACA), one of which is the controversial 2.3 percent tax on medical devices. The device tax, which was introduced as an offset to some of the costs of the ACA, was suspended for a two-year period terminating at the end of calendar year 2017, a time during which device makers said they were able to resume hiring and restore funding for research and development. A number of Senate Democrats from med-tech-intensive states...

Tryton Medical Inc. has garnered an FDA approval for its Side Branch Stent to treat coronary artery disease with lesions at major branches. This is the first approval for a dedicated bifurcation device in the U.S., according to the Durham, N.C.-based company. Cordis, part of Dublin, Ohio-based Cardinal Health Inc., has already signed a deal to be the sole U.S. distributor of the stent. The Cordis deal dates back to last October, and the group is slated to launch the Side Branch Stent via its interventional vascular business later this month. Although the financial details...

Boston Scientific Corp. received a split decision from a U.K. patent court in its transcatheter aortic valve replacement (TAVR) patent infringement lawsuit against Edwards Lifesciences Corp. The court determined one of Marlborough, Mass.-based Boston Scientific's patents asserted against Edwards is valid and infringed. The court also ruled that a second patent related to the outer seals for the technology was found to be invalid. Boston Scientific has developed the Lotus Valve for TAVR, which received approval in Europe back in 2013, but has yet to receive a nod from the FDA. Irvine, Calif.-based Edwards' Sapien...

Tandem Diabetes Care Inc. has developed a tool for the remote deployment of its insulin pump software. The device updater will allow diabetes patients with the t:slim insulin delivery system to have access to new features, without having to wait on reimbursement to buy a new pump. Provisions of a patient's insurance plan typically limit eligibility for a new pump. Patients are often unable to receive the benefits of any new innovations or features that come out after they've received pumps. But the San Diego-based company's remote deployment tool allows patients to receive updates throughout...

Liquid biopsy startup Grail Inc. said it has raised more than $900 million through the first close of its series B round, putting it on the path to develop a blood-based test for cancer screening. The Menlo Park, Calif.-based company is slated to bring in more than $1 billion in the round and could close on the remainder of the investment prior to the end of 1Q17. Arch Venture Partners led the financing, with participation from Johnson & Johnson Innovation, Amazon Inc., Bristol-Myers Squibb Inc., Celgene Corp., Varian Medical Systems Inc. and Merck & Co....

Viewray Inc. received FDA clearance for the Mridian Linac system, a device that allows clinicians to visualize in real time the movement of tumors and organs during radiation treatment. The Oakwood, Ohio-based company's technology, which also has CE mark approval, combines MRI guidance with linear accelerator radiation. Viewray's president and CEO, Chris Raanes called the clearance a milestone for the company. First-generation Mridian technology, which uses cobalt-60 therapy for therapy, received FDA clearance back in 2012. (See Medical Device Daily, May 31, 2012.) "We spent an awful lot of time explaining to the world why...