Philips receives FDA warning letter over quality issues

The warning follows inspections of three Philips facilities that found failures to meet standards for reporting complaints and corrective actions.

By Elise Reuter • Oct. 30, 2025

Dexcom faces proposed class action suit over G7 CGM problems

The parent of a child who wore the device to manage diabetes described failed alerts and inaccurate readings in a complaint.

By Elise Reuter • Oct. 20, 2025

Oz speaks out about shutdown, Medicaid cuts, Medicare Advantage audits and more

Six takeaways from the CMS administrator’s appearance at a D.C. think tank Monday — including who’s set to be the next Medicaid director.

By Rebecca Pifer • Oct. 8, 2025

MedTech Europe pressures EU to make regulatory changes by early 2026

The request includes a call to postpone re-certification requirements for devices already certified under the medical technology regulations.

By Nick Paul Taylor • Sept. 26, 2025

White House asks Supreme Court to uphold Trump’s tariff powers

The government submitted a 49-page brief urging the high court to affirm Trump's broad emergency levies.

By Antone Gonsalves • Updated Sept. 22, 2025

Exactech agrees to $8M settlement over defective knee implants

The payment resolves allegations brought by the Department of Justice that Exactech violated the False Claims Act by selling knee implants with components that failed prematurely.

By Elise Reuter • Sept. 19, 2025

FDA rescinds LDT final rule

Regulation of lab developed tests returns to its status before the agency attempted to expand its jurisdiction and industry groups sued to stop it.

By Susan Kelly • Sept. 19, 2025

House committee advances Medicare coverage bill for breakthrough devices

AdvaMed welcomed the committee’s work on the legislation but called for the inclusion of diagnostics in the bill.

By Nick Paul Taylor • Sept. 18, 2025

FTC warns healthcare companies about restrictive noncompete contracts

Chair Andrew Ferguson has sent letters to large healthcare employers and staffing firms asking them to review their employment contracts as the FTC pursues targeted enforcement of illegal noncompetes.

By Rebecca Pifer • Sept. 12, 2025

Supreme Court to hear Trump’s tariff legality case in November

The high court granted an expedited review of an appellate court finding that the president's sweeping tariffs were illegal.

By Antone Gonsalves • Sept. 10, 2025

Philips under investigation by Paris Prosecutor’s Office over recalled respiratory devices

The prosecutor’s office opened an investigation in June, with charges including aggravated fraud and failure to report incidents that pose serious health risks.

By Elise Reuter • Sept. 10, 2025

Judge allows Epic antitrust suit to move forward

A judge dismissed several claims brought by startup Particle Health against the EHR giant, but allowed some federal allegations to continue in court. 

By Emily Olsen • Sept. 9, 2025

Appellate court rules Trump’s global tariffs illegal, but delays action

The court intends to strike down the tariffs by mid-October, pending a Supreme Court review of the ruling.

By Antone Gonsalves • Sept. 2, 2025

Apple updates smart watches with blood oxygen feature after customs ruling

Apple said it was able to bring a redesigned blood oxygen feature to its devices after a recent U.S. customs ruling.

By Elise Reuter • Aug. 14, 2025

FTC moves to block Edwards’ JenaValve acquisition

Edwards Lifesciences and JenaValve said they remained committed to completing the deal and would defend the case in court.

By Susan Kelly • Aug. 6, 2025

Quest, Labcorp downplay ‘Big Beautiful Bill’ impact

Executives at the laboratory companies said they expect the effects on testing services from the Republicans’ tax and domestic policy bill, including cuts to Medicaid, will be minimal.

By Susan Kelly • July 29, 2025

EU, Canada delay retaliatory tariffs against US

Meanwhile, Brazil announced its own countermeasures while Mexico remains confident it will reach a deal by Aug. 1.

By Philip Neuffer • July 15, 2025

Court orders HHS to restore webpages related to ‘gender ideology’

A federal judge ordered the government to reinstate critical documents as soon as possible, but left the door open for the Trump administration to take a second crack at removing the data.

By Susanna Vogel • July 8, 2025

Carmat files for insolvency amid cash crunch

The artificial heart maker ran a crowdfunding campaign to try to raise some of the 3.5 million euros it needed to fund operations into July.

By Nick Paul Taylor • July 1, 2025

Supreme Court upholds ACA preventive services mandate

The high court preserved a key portion of the Affordable Care Act that requires private insurers to cover a range of preventive healthcare services without cost sharing.

By Emily Olsen • June 27, 2025

Could the FDA take an indirect approach to regulate LDTs?

Attorneys said many questions remain about LDT regulation after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

By Susan Kelly • June 16, 2025

Vaccine makers face fresh uncertainty after firing of CDC panel

The abrupt termination of the 17 panelists guiding the CDC’s vaccine recommendations could yield a new committee more aligned with Robert F. Kennedy Jr.’s skeptical views, analysts warned.

By Delilah Alvarado • June 10, 2025

Owens & Minor spikes $1.36B Rotech buyout over regulatory barriers

The companies scrapped the merger because securing FTC clearance “proved unviable in terms of time, expense and opportunity.”

By Nick Paul Taylor • June 6, 2025

FDA declines to appeal court order that stopped LDT final rule

“The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen analysts wrote.

By Susan Kelly • June 3, 2025

US court blocks Trump’s sweeping tariffs

The Court of International Trade said the president overstepped his authority, halting various duties. After an appeal, the ruling has been paused.

By Edwin Lopez • Updated May 29, 2025