Good news bracketed July for Teleflex Inc. as it completed the acquisition of the vascular intervention business of Berlin-based Biotronik SE & Co. for €760 million (US$879 million) on July 1 and released stronger-than-expected second quarter results on the closing day of the month. Both bode well for the company as it proceeds through a thorough restructuring announced in February.

Negotiations for the sixth U.S. FDA device user fee agreement (MDUFA VI) are officially underway, and the Aug. 4 meeting highlighted some of the differences between the agency’s and industry’s expectations.

The FDA announced July 17 that Dexcom Inc. recalled a series of continuous glucose monitor receivers for a failure of speakers to issue an alert for out-of-specification blood glucose measures. This is a clear demonstration of the principle that greater device functionality often creates new types of risk.

While inflation in the U.S. is hovering below 3%, increases in some FDA user fees for fiscal 2026 are tripling that rate. PDUFA fees for branded prescription drugs and biological products will see a 9% hike come Oct. 1, and the increase in MDUFA fees will more than double the inflation rate with a 7% hike across the board.

Like waves crashing on the beach, med-tech IPOs keep on coming. Heartflow Inc. set terms for its IPO on Aug. 1, offering 12.5 million shares at a price range of $15 to $17 per share. At the top of the range, the company could raise a sunny $212.5 million. It plans to list on the Nasdaq with the symbol “HTFL.”

The U.S. Department of Justice announced July 31 that Illumina Inc. agreed to pay $9.8 million to settle allegations it sold genomic sequencing equipment that suffered from cybersecurity problems. The settlement concludes a qui tam lawsuit filed by a former employee and highlights the hazards of poor cybersecurity for med-tech firms.

While U.S. President Donald Trump’s country-by-country reciprocal and newly negotiated tariffs go into effect today, a separate, global biopharma sector tariff of, possibly, 200% continues to loom over the sector. For many stakeholders, a biopharma sector tariff of even 25%, as first proposed by Trump, would be a disaster in the making, especially when combined with the pressures of Medicare price negotiations and the president’s escalation of most-favored-nation pricing.

The Senate Appropriations Committee met July 31 to markup legislation that would fund the Department of Health and Human Services – including an additional $400 million for the National Institutes of Health. The increase in NIH funding repudiates the Trump administration’s efforts to drastically cut those appropriations, which is an outcome marking a clear win for companies in the life sciences.

Alterity Therapeutics Ltd. helped develop a new neuroimaging biomarker called the multiple system atrophy index (MSA-AI), which looks to be a more reliable biomarker for tracking disease progression of MSA. Developed using deep learning methods, the MSA-AI offers a superior, objective and quantifiable measure of brain atrophy in MSA patients.

The U.S. Court of Appeals for the Federal Circuit recently returned a decision in a case pitting Shockwave Medical Inc. against Cardiovascular Systems Inc. in a decision that adds a new wrinkle to the question of how prior art can and cannot be used to eviscerate a patent.