Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA nod for tissue containment in power morcellation comes amid ongoing review of cancer concerns

Irish startup Advanced Surgical Concepts has nabbed an FDA nod for its tissue containment system for use with certain laparoscopic power morcellators. The regulatory go-ahead falls under the agency's de novo process that's reserved for low- to moderate-risk devices that are novel.

Feds roll out new tool for mobile health app development geared toward security

The FTC and FDA are rolling out a new web-based tool for companies making mobile health apps that helps them understand which laws and regulations apply to their products, especially regarding security.

Medtronic artificial pancreas may hit the market next spring, as pivotal trial nears final data

An artificial pancreas, a device that automatically regulates insulin dosage for Type 1 diabetes patients based on real-time glucose data, may be a reality soon. Medtronic is nearing final data for a pivotal trial of its Hybrid Closed Loop System. It reportedly expects to submit to FDA for approval by the end of June, with an anticipated launch by April 2017.

UPDATED: FDA approves first leadless transcatheter pacemaker for Medtronic, St. Jude up next

Medtronic has won the first U.S. approval for a leadless pacemaker from the FDA. The inch-long device is the smallest available and is implanted directly into the heart's right ventricle chamber. Traditional pacemakers require wired leads to connect the device to the heart.

Allergan amps up #ActuallySheCan campaign with Tribeca festival films

Remember Allergan's hashtag-heavy, emoji-laden female empowerment campaign, #ActuallySheCan? It hasn't faded out since purple-haired spokes-character Violet first made her debut. On the contrary, it's about to take center stage--literally.

Medtronic: Proposed U.S. Treasury tax inversion regs won't have an impact

Medtronic has assured its investors, again, that moves by the U.S. Department of Treasure to block tax inversions will not have any material impact on it. Its latest statement is in response to temporary regulations on inversions and proposed regulations on earnings stripping that were released earlier this week by the Treasury Department.

Celltrion's Remicade biosim kneecapped Merck in Europe. Can it do the same to J&J in the U.S.?

The FDA has officially green-lighted the Remicade biosimilar Inflectra, a med from South Korea's Celltrion and Pfizer's Hospira. But will the knockoff be able to capture the same kind of market share from Johnson & Johnson that it's been stealing in Europe from Merck & Co.? Depends who you ask.

Drug price cuts in Japan sink in though details sparse

Domestic and foreign drugmakers in Japan may cut spending on R&D as the scope of mandated price cuts for reimbursed products kicks in--suggesting that future investments are at stake.

South Korea's Celltrion gets U.S. FDA nod for Remicade biosimilar Inflectra

The hits keep coming for South Korean biosimilar makers with Incheon-based Celltrion snapping up a U.S. FDA approval for a biosimilar of Johnson & Johnson's Remicade, which follows crosstown rival Samsung Bioepis getting an endorsement from the EMA for its version of the drug, Flixabi.

ConforMIS withdraws FDA submission for iTotal Hip, to resubmit in second half

Personalized 3-D printed joint implants may seem like a no-brainer. But troubled small-cap ConforMIS has struggled to dig in its heels since a $135 million IPO last June. Last fall, the implant maker faced a recall due to packaging problems. And now the FDA has forced its hand on a regulatory submission for a hip implant--causing it to withdraw the application in the face of unanticipated questions.