Kestra Medical recently filed a form S-1 to confirm its intent to go public through an initial public offering (IPO).

Outset Medical (Nasdaq: OM) announced today that the FDA says it addressed all issues cited in a 2023 warning letter.

The US Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in ...

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...

AB (market cap: $16.28M), a company in the development stage, provided insights into its Q4 2024 performance and future plans during its recent earnings call. The company is advancing its Neola ...

Our experts explain the science behind red light therapy, and if it really works. Plus, we recommend some FDA-cleared wands ...

With the announcement of this new FDA-approved pain medication comes a new class of pain relief that ... headphones, and gaming devices. Whenever he isn’t busy writing about tech or gadgets ...

The future of medical devices has much potential, but they also have risks related to cybersecurity. In 2024, we saw the first full year of the Food and Drug Administration’s (FDA) new guidance ...

Journey Medical, a specialty pharmaceutical company, focuses on dermatology and has achieved cashflow breakeven with its current $55mm-$60mm revenue and sales infrastructure. The FDA-approved ...

“With the approval of JOURNAVX, a non-opioid, pain signal inhibitor and the first new class ... for medical advice about side effects. Patients may report side effects to the FDA at 1-800 ...

Approval of Journavx for acute pain marks the first new class of acute pain medication approved by the FDA in over 20 years. The FDA has approved Vertex Pharmaceuticals’ Journavx (suzetrigine), a ...