HCmed Innovations announced that the FDA has granted 510(k) clearance to the company’s AdheResp connected breath-actuated mesh nebulizer, which delivers aerosol during inhalation only. According to the company, AdheResp is the first nebulizer of its type with built-in connectivity to receive 510(k) clearance. HCmed notes that the AdheResp can be used for delivery temperature-sensitive therapies, including biologics.
In 2022, HCmed announced that it had partnered with Formosa Laboratories and Formosa Pharmaceuticals to offer development and manufacturing services for inhaled drugs through to commercialization. The new announcement also cites the company’s in-house manufacturing capabilities as a factor in accelerating clinical development.
HCmed Innovations CEO Jason Cheng commented, “Achieving this regulatory milestone underscores HCmed’s commitment to pioneering innovative solutions for drug development and reinforces our leadership in the CDMO field. We will continue expanding regulatory approvals and strategic collaborations to advance our global presence.”
Read the HCmed Innovations press release
