Management is beaming with delight at Heartbeam Inc. as the company's appeal strategy paid off with U.S. FDA clearance for its synthetic 12-lead electrocardiogram software for the assessment of arrhythmias. In November, the Santa Clara, Calif.-based company received a Not Substantially Equivalent determination from the agency on its 510(k) application, which could have substantially delayed commercialization. Following a plan disclosed Nov. 28, the company resolved the agency's issues through an appeal process and active engagement and obtained clearance much more quickly than expected.
Alcon AG reported on Dec. 9 that it had sweetened its offer for intraocular lens maker Staar Surgical Co., raising its offer by roughly 10% to $30.75 a share from its prior bid of $28 a share. The revised offer comes on the heels of the expiration of Staar’s go-shop period on Dec. 8, in which Lake Forest, Calif.-based Staar said no superior offers were received.
Roche AG received CE mark for its cobas Bacterial Vaginosis/Candida Vaginitis assay, which will help to improve accuracy in detecting vaginitis in women. The molecular test identifies specific bacteria and yeast responsible for BV and CV from vaginal samples collected using the cobas PCR Media proprietary tube.
New hires and promotions in the med-tech industry, including: Berlin Heals, Billiontoone, Boston Scientific, Cathvision, Fresenius, Retinalgenix, Turncare.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bendit Technologies, Heartbeam, Kane Biotech, Proverum, Vektor Medical.
The UK Health Security Agency (UKHSA) has identified a new recombinant strain of mpox (formerly monkeypox) that contains elements of clade Ib and clade IIb of the virus, in a traveler who recently returned from Asia. In a paper describing the new strain, the researchers at UKHSA say it is not possible to determine from a single genome how long the recombinant virus has been in circulation, or whether it will have a fitness benefit over currently circulating lineages.
Seventy-three pharmaceutical, biotechnology and medical device companies from mainland China filed for IPOs in Hong Kong this year, a review by BioWorld found. In the second half of 2025, 43 new securities reports were filed on the Hong Kong Stock Exchange, increasing from the 30 applications in the first half.
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