With the off-label/intended use controversy still simmering, a bill has debuted in the U.S. House of Representatives that would restrict the federal government's ability to pursue charges against manufacturers of drugs and devices based merely on "actual or constructive knowledge" on the part of the manufacturer that the drug, device or biologic will be used outside the FDA-approved labeling. Should the bill pass into law, it would close the book on one of the most hotly contested areas of commercial speech law in recent memory, but there are skeptics about the need for such legislation....

PARIS – It's almost official. After eight years of hard-fought negotiating, the European Parliament repealed the 30-page Medical Device Directives governing the Conformité Européen certification, or CE Mark, and adopted the 600 pages of the Medical Device Regulation (MDR) and In vitro Diagnostic Medical Devices (IVDR). No one in Europe is celebrating. Though April 5, 2017 was called "an historic day for our industry" by the German Medical Association BVMed, based in Berlin, before it carefully described a potential train wreck the new legislation has put in motion. (See Medical Device Daily, Feb. 27, 2017.)...

LONDON – Members of parliament scrutinizing the Brexit process have called for a standalone agreement to be made to protect the rights of EU27 nationals living in the U.K. and British citizens in mainland Europe as soon as negotiations on the terms of the U.K.'s exit from the EU begin. An agreement on reciprocal rights should be reached as a matter of priority and be a separate deal that is not dependent on any other exit arrangements or trade deals, MPs on the parliamentary committee on Exiting the European Union said in a report published...

Private equity firm Apax Partners is continuing to keep the medical aesthetics market space hot with its proposed acquisition of Syneron Medical Ltd., also known as Syneron Candela, for $397 million. The acquisition price represents a 15 percent premium to the Yokne'am Illit, Israel-based company's 90-day average closing price through Feb. 10. News of the deal caused Syneron's shares (NASDAQ:ELOS) to rise as high as 6.9 percent during Monday trade. Shares closed at $11.10 up about 5.2 percent. The Syneron board unanimously approved the transaction. Shimon Eckhouse, who owns 7.4 percent of the company, has...

Endologix Inc. is on a path to expanding its Ovation platform through its ELEVATE IDE clinical study. The Irvine, Calif.-based company said the 75-patient trial will evaluate the safety and effectiveness of its Ovation Alto abdominal stent graft system for the repair of infrarenal abdominal aortic aneurysms (AAA). The company said the first patients have already been treated in the trial. Ovation Alto broadens Endologix's reach into the endovascular aortic repair (EVAR) market and provides treatment options for patients with complex AAAs. The device is specifically targeted toward patients with very short or otherwise challenging...

Boston Scientific Corp. will acquire Symetis SA for $435 million in cash in an effort to broaden its transcatheter aortic valve replacement (TAVR) portfolio. The Ecublens, Switzerland-based company had been expected to list publicly at the end of this month on the Euronext Paris market in an offering slated to raise €55.8 million (US$59.9 million). Instead, the Marlborough, Mass., cardiovascular giant has scooped up Symetis, which has two EU marketed TAVRs with a next-gen iteration in the clinic. Wall Street evinced some concern that the addition of Symetis' Acurate platform to Boston Scientific's existing Lotus...

New research published in the BMJ finds that total knee replacement may be most useful in osteoarthritis patients with the most severe symptoms, with little quality of life or economic benefit from the use of the procedure in the less severe patient population. The researchers suggested that a more rigorous assessment for individual patients of the potential risks and benefits of knee replacement, as well as better optimization of more conservative interventions, could help to improve population-level outcomes and the economic utility of the procedure. The study authors call for further research to advance these...

Organogenesis Inc. is set to acquire Nutech Medical Inc. a private company and supplier of tissue products used in spinal and orthopedic surgeries. Financial details surrounding the deal were not disclosed. Canton, Mass.-based Organogenesis has been waiting to enter the amniotic tissue market, which led to it picking up Nutech Medical. "The acquisition expands Organogenesis' product profile into the surgical, orthopedic, spine and amniotic wound care markets and unites two pioneering companies, each with decades of experience in bringing quality biologics products to patients around the world," Gary Gillheeney, president and CEO of Organogenesis, told...

iCAD Inc. has secured a PMA approval from the FDA for the computer-aided detection product for digital breast 3-D tomosynthesis that is based on deep learning. The product is already available via Chicago-based partner GE Healthcare; the Nashua, N.H., start up is working now to make it available to other major tomosynthesis providers. Known as Powerlook Tomo Detection, it received a CE mark and Health Canada approval last year. In Europe, it's already in use at multiple high-volume breast imaging centers. APPLYING DEEP LEARNING "The way the product works is that we have developed a...

Newly published guidelines from the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) support cardiac monitoring devices in evaluating syncope patients. The "2017 ACC/AHA/HRS guideline for the evaluation and management of patients with syncope" was recently published online in the Journal of the American College of Cardiology, Circulation and Heartrhythm. American College of Emergency Physicians and the Society for Academic Emergency Medicine also helped draft the guidelines. The new measures point out the choice of a specific cardiac monitor should be determined on the basis of the...