Blood pressure monitor with EKG available for pre-order
The new Complete blood pressure monitor with EKG capability from Omron Healthcare, in partnership with AliveCor, is now available for preorder in the U.S. on Omron’s website.
Latest News
Targeted therapy for metastatic bladder cancer approved by FDA
Balversa is the first targeted therapy to receive approval by the U.S. Food and Drug Administration for adult patients with advanced metastatic bladder cancer with the genetic alteration called FGFR3 or FGFR2 that progressed during or after platinum-containing chemotherapy.
Tentative FDA approval granted for generic Sernivo
The Food and Drug Administration (FDA) has given tentative approval for the generic version of Sernivo Spray 0.05% from Perrigo Company.
FDA grants De Novo review to LOADPRO spine sensor
The U.S Food and Drug Administration granted a De Novo review for a device intended to be used in the spine.
FDA Market Clearance for new Cranial Electrotherapy Stimulator
A new treatment for anxiety, depression and insomnia may be on the way now that Innovative Neurological Devices received FDA market clearance for its Cervella Cranial Electrotherapy Stimulator (CES).
Medical screw with superalloy receives FDA approval
The Europa Pedicle Screw System received FDA 510(k) approval at the end of March.
FDA releases statement on new policies to curb youth access to flavored tobacco products
The Food and Drug Administration is looking toward a future where combustible cigarettes are not addictive and do not harm as many people as are currently affected by nicotine and additive chemicals.
Gottlieb weighs in on naming scheme for biological medicines for competition and patient safety
Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb released a statement last week on the importance of naming biological medicines that will benefit by having a lower cost to patients.
FDA finds 32,000 malfunctions, 366 deaths involving surgical staples over seven years
The Food and Drug Administration (FDA) is acknowledging a rise in medical device reports concerning surgical staples and staplers used internally.