BioWorld MedTech Jan. 3, 2023

Investors not so hot on Burning Rock despite breakthrough designation for multi-cancer diagnostic

Burning Rock Biotech Ltd.’s share price flared up on Tuesday morning on news of U.S. FDA breakthrough device designation for its Overc multi-cancer detection blood test (MCDBT). The stock closed on Dec. 30, 2022, at $2.26 and rose sharply on the announcement to open at $2.89. By the end of the day, however, the stock had sunk to $2.15. Read More

Alung’s de novo for extracorporeal carbon dioxide removal requires extensive in vivo testing

The U.S. FDA has released the special controls needed for extracorporeal carbon dioxide removal thanks to the successful pursuit of a de novo petition by Pittsburgh-based Alung Technologies Inc., but generating the clinical data for successor 510(k) devices will be no mean feat. While some of the associated in vivo testing may be performed on animal models, the list is extensive and includes testing for hemodynamic instability and inadequate gas exchange, all reasons that Alung and the FDA needed the better part of a decade to bring this device to the U.S. market. Read More

MHRA advocates use of synthetic datasets in clinical trials

The U.K. Medicines and Healthcare products Agency (MHRA) reported a trio of research projects as part of a push to maintain its reputation as a leading regulator of drugs and medical devices now the U.K. is no longer part of EU regulatory systems, and to attract clinical trials - and the associated inward investment - despite no longer offering access to the EU single market. Read More

Novel SPECT imaging technique may measure absorbed dose from radiation therapy

Engineers from Washington University in Saint Louis are developing a novel imaging technique for evaluating the use of alpha-particle emitting radiopharmaceutical therapy in tumors and other radiation-sensitive organs of the body. They have tested a low-count quantitative single-photon emission computed tomography (LC-QSPECT) method to provide reliable measurements of the radionuclide uptake in lesions and at-risk organs after its administration. Read More

Cryofocus nets $27M in Hong Kong IPO for interventional cryotherapy devices

Cryofocus Medtech (Shanghai) Co. Ltd. has raised HK$210 million (US$27 million) on the Hong Kong Stock Exchange. Its shares opened at HK$18.5 apiece, fell over 6% and closed at HK$17.66 on the first trading day of Dec. 30, 2022. Its shares closed at HK$16.8 per share on Jan. 3, 2023. Read More