News

Lenox MacLaren's grinding court battle with Medtronic will continue

A federal appeals court panel ruled that Lenox MacLaren Surgical has sufficient grounds to take Medtronic ($MDT) back to court over monopolization claims against the Minnesota-based medical device giant.

UCLA researchers develop wearable biosensor for detecting GI disorder postsurgery

Researchers have developed a device that could determine how soon patients should be fed following surgery. Patients with the intestinal problem postoperative ileus fall sick if they eat too soon after surgery and must stay in the hospital for an additional two to three days.

Smaller med techs suffer under excise tax burden

Although the biggest med tech companies likely pay the bulk of the reported $1.4 billion in excise taxes levied on the industry during its first year in 2013, the tax adds to an already heavy burden for small and midsized companies.

Danish devicemaker homes in on next-generation hearing aid to jump-start sales

Danish hearing aid outfit GN ReSound is rolling out new growth strategies, homing in on its next-generation hearing aid device as a way to jump-start sales and boost its market share.

Med tech M&A speculation swirls around Nobel, CareFusion

Dental company Nobel Biocare is reported to have attracted some suitors in its quest to sell itself, while speculation arises that healthcare analytics and management company CareFusion could be next up for a big M&A deal.

Heart pump implant combined with gene therapy in new trial

Celladon has announced the beginning of a trial it hopes will determine the feasibility of using MYDICAR in heart failure patients using left ventricular assist devices.

Medtronic hires former senators to lobby against anti-inversion bill and protect acquisition of Covidien

Medtronic quietly hired former Sens. John Breaux (D-LA) and Trent Lott (R-MS) and three others as lobbyists to combat anti-inversion legislation as political anger over the tax saving method mounts, threatening the planned company's planned merger with Covidien. 

Sunshine Act payments database offline, rollout of initiative delayed

The Centers for Medicare & Medicaid Services took offline the payments database used by drug and device makers to disclose payments to doctors and teaching hospitals under the Sunshine Act, a part of the Affordable Care Act. CMS's action came in response to complaints that some doctors could see the payments made by other doctors.

Imaging pen may detect skin cancer faster

Researchers have developed and are pilot testing an imaging pen that uses three different spectroscopic mechanisms to view a skin lesion. The device has the potential to identify suspected skin cancer tumors earlier and cut the costs of unnecessary biopsies.

Med tech M&A gets much, much bigger during the first half

Not only are we going to walk you through the top med tech M&A deals of the first half of 2014, but we will take a look back to how the acquisitions from the first half of 2013 are working out and if the acquirer got exactly what they bargained for.

Volcano guides lower but offers long-term vision, Wall Street trims by as much as 25%

Volcano didn't get investors to buy into the idea of short-term pain superseded by long-term gain. The intravascular imaging and peripheral device company reduced its guidance for the year and laid out a plan for the company that includes the divestiture of its Axsun business.

Boston Scientific down on disclosure of subpoena about Bridgepoint acquisition

A Securities and Exchange Commission filing from Aug. 6 disclosed that Boston Scientific received a subpoena from the U.S. Attorney for the District of New Jersey regarding its acquisition of Bridgepoint Medical, leading to a sharp decline in trading. 

Four unanswered questions about the looming LDT regulations

The FDA described the contents of its proposed regulatory framework to Congress, but the details of its plan remain a mystery. Following the July 31 notification to Congress, the agency must wait at least 60 days before the release of its draft guidance on the topic.

Google releases health and fitness developers' kit

Google released a preview of its software development kit for fitness apps on Aug. 7. The software will interact with wearable devices and enable a variety of apps to benefit from information about a user's fitness history stored on a centralized interface.

GE-funded NGO aims to repair developed-world medical devices in the developing world

General Electric's $2 billion commitment to invest in Africa includes the launch of a program to train biomedical engineering technicians in Nigeria, where patients are dying of treatable conditions because the devices to treat them are left unfixed due to a lack of know-how, according to a prominent nongovernmental organization.

Physicians hesitate to use HeartMate II pump after NEJM study, Thoratec down 30%

Thoratec shed almost one-third of its value after reporting abysmal second quarter earnings. The advanced heart failure device company attributed most of the miss to a New England Journal of Medicine article that came out late last year and linked the company's HeartMate II left ventricular assist device to an increasing rate of pump thrombosis.

Medtronic and Covidien face FTC pushback for pending merger

As the regulatory climate for corporate tax inversions reaches a boiling point, Medtronic is facing heightened government scrutiny for its pending merger with Covidien.

Device to combat wet AMD spreads in Europe, spurs NIH interest

Wet age-related macular degeneration is the leading cause of blindness in the developed world. The standard of care calls for about 8 costly injections into the eye of medication containing anti-VEGF (vascular endothelial growth factor) per year. "In the real world having patients maintain that level of monitoring and therapy just does not happen," Jim Taylor, who has struggled to convince his aging mother to receive the therapy, told FierceMedicalDevices in an interview.

Roche, Quintiles partner for companion diagnostics in China

Ventana and Quintiles are partnering up to provide companion diagnostic testing services in China for early clinical trials. China is among a few countries that requires patient samples used in clinical trials to be tested domestically for inclusion in the country's approval process.

Scientists work toward faster, easier, cheaper Ebola diagnostics

While test strips and expensive polymerase chain reaction (PCR) machines exist in the Ebola detection market, scientists are after a medical device that can detect and prevent the spread of Ebola at a low cost.