Philips shares fall 9% after U.S. drug regulator deals fresh blow to sleep device recall

Biotech
Friday, October 6th, 2023 1:49 pm EDT

Key Points

  • Philips, a Dutch health tech company, experienced a significant decline in its stock price after the U.S. Food and Drug Administration (FDA) criticized its handling of a major product recall, causing the company’s shares to fall more than 9% in London trading.
  • The FDA expressed concern that Philips’ testing and analysis of the recalled ventilators used for treating sleep apnea were inadequate to fully assess the risks posed to users. The FDA requested additional testing, and Philips agreed to comply with this request.
  • Philips responded by emphasizing its commitment to patient health and safety, stating that its top priority is to provide replacement devices and conduct further testing to ensure the safety of the recalled sleep and respiratory care devices. The company expressed alignment with the FDA and other regulators in maintaining high standards of patient safety and healthcare quality.

Shares of Dutch health technology company Philips experienced a significant drop, falling over 9% in London trading, following a statement from the U.S. Food and Drug Administration (FDA). The FDA expressed dissatisfaction with Philips’ handling of a major product recall involving millions of ventilators used to treat sleep apnea. The FDA stated that the testing and analysis provided by Philips were inadequate to assess the risks associated with the recalled devices fully. Philips agreed to perform additional testing as requested by the FDA. The recall has been a major concern for the company, with CEO Roy Jakobs previously emphasizing its high priority. Philips responded by affirming its commitment to patient health and safety and its willingness to work with regulators to ensure high standards in healthcare delivery.

For full original article on CNBC, please click here: https://www.cnbc.com/2023/10/06/philips-shares-fall-after-fda-says-sleep-device-recall-inadequate.html