Get all your news in one place.

100's of premium titles.
One app.

Get all your news in one place.

100's of premium titles. One news app.

Benzinga

Business

Avi Kapoor

Why Heartbeam Shares Are Trading Higher By Around 43%; Here Are 20 Stocks Moving Premarket

Food and Drug Administration TMC

Section,Of,A,Financial,Newspaper,Titled,Key,Movers

Shares of Heartbeam Inc (NASDAQ:BEAT) rose sharply in pre-market trading after announcing its regulatory strategy following the Food and Drug Administration’s Not Substantially Equivalent (NSE) decision on its 12-lead Electrocardiogram Synthesis Software.

The Santa Clara-based medical technology company is pursuing multiple options, including an appeal process or a 510(k) resubmission, a premarket FDA filing showing the device is equivalent to legally marketed products.

Sign up to read this article

Read news from 100's of titles, curated specifically for you.

Already a member? Sign in here

Top stories on inkl right now

Houston Physician Indicted in Alleged $30 Million Scheme Billing Federal COVID Program for Office Visits That Never Happened

Houston Physician Indicted in Alleged $30 Million Scheme Billing Federal COVID Program for Office Visits That Never Happened

A Houston doctor faces fraud charges over an alleged $30 million scheme billing a federal COVID program for uninsured patients. What the case alleges.

Okaloosa Mandatory Evacuation Covers Zones A and B as Hurricane Isaias Threatens 5- to 7-Foot Storm Surge

Okaloosa Mandatory Evacuation Covers Zones A and B as Hurricane Isaias Threatens 5- to 7-Foot Storm Surge

Okaloosa County ordered Zones A and B to evacuate as Hurricane Isaias nears. Shelter sites, special needs registration, and surge risks are explained.

Florida Drops Moral Exemption From Vaccine Rule but Still Plans to End Four School and Child Care Requirements

Florida Drops Moral Exemption From Vaccine Rule but Still Plans to End Four School and Child Care Requirements

Florida removed a proposed moral vaccine exemption but still plans to end four school shot rules. What parents should know after Thursday's hearing.

Missouri Deputy Struck Persephone Berger, 16, as Family Accuses Police of Misleading Them About Hit-And-Run

Missouri Deputy Struck Persephone Berger, 16, as Family Accuses Police of Misleading Them About Hit-And-Run

Persephone Berger, 16, died after a Missouri deputy struck her on a roadway. Her family says they were initially told it was a hit-and-run.

International Business Times UK

One subscription that gives you access to news from hundreds of sites

Already a member? Sign in here

How to watch NASCAR at Charlotte II: Weekend schedule, start time, entry list, TV

How to watch NASCAR at Charlotte II: Weekend schedule, start time, entry list, TV

NASCAR is racing at the Charlotte Motor Speedway oval this weekend, but inclement weather from an approaching hurricane may impact on-track activity

Democratic senator says Hegseth trying to hide costs of Iran war from US public

Democratic senator says Hegseth trying to hide costs of Iran war from US public

Chris Murphy says Pentagon blocked him from military base in Qatar and Iran strike on US embassy in Riyadh far worse than public led to believe

The Guardian - US

Related Stories

Top stories on inkl right now

Houston Physician Indicted in Alleged $30 Million Scheme Billing Federal COVID Program for Office Visits That Never Happened

Houston Physician Indicted in Alleged $30 Million Scheme Billing Federal COVID Program for Office Visits That Never Happened

A Houston doctor faces fraud charges over an alleged $30 million scheme billing a federal COVID program for uninsured patients. What the case alleges.

Okaloosa Mandatory Evacuation Covers Zones A and B as Hurricane Isaias Threatens 5- to 7-Foot Storm Surge

Okaloosa Mandatory Evacuation Covers Zones A and B as Hurricane Isaias Threatens 5- to 7-Foot Storm Surge

Okaloosa County ordered Zones A and B to evacuate as Hurricane Isaias nears. Shelter sites, special needs registration, and surge risks are explained.

Florida Drops Moral Exemption From Vaccine Rule but Still Plans to End Four School and Child Care Requirements

Florida Drops Moral Exemption From Vaccine Rule but Still Plans to End Four School and Child Care Requirements

Florida removed a proposed moral vaccine exemption but still plans to end four school shot rules. What parents should know after Thursday's hearing.

Missouri Deputy Struck Persephone Berger, 16, as Family Accuses Police of Misleading Them About Hit-And-Run

Missouri Deputy Struck Persephone Berger, 16, as Family Accuses Police of Misleading Them About Hit-And-Run

Persephone Berger, 16, died after a Missouri deputy struck her on a roadway. Her family says they were initially told it was a hit-and-run.

International Business Times UK

One subscription that gives you access to news from hundreds of sites

Already a member? Sign in here

How to watch NASCAR at Charlotte II: Weekend schedule, start time, entry list, TV

How to watch NASCAR at Charlotte II: Weekend schedule, start time, entry list, TV

NASCAR is racing at the Charlotte Motor Speedway oval this weekend, but inclement weather from an approaching hurricane may impact on-track activity

Democratic senator says Hegseth trying to hide costs of Iran war from US public

Democratic senator says Hegseth trying to hide costs of Iran war from US public

Chris Murphy says Pentagon blocked him from military base in Qatar and Iran strike on US embassy in Riyadh far worse than public led to believe

The Guardian - US

Our Picks

Woman finds a white purse at a thrift store. Then she unzips a small pocket and realizes it isn’t empty: ‘This is crazy’

That was a surprise!

We Got This Covered

Pop Star Britney Spears Reportedly Branded 'Clueless' by Critics Over Recent Dollywood Ride Video

Britney Spears shared footage from a family visit to Dollywood, praising the Tennessee attraction, while some online viewers criticised the language heard during a spinning-ride video.

International Business Times UK

What Happened to Travis Barker? Musician Shares Hospital Photos as Kourtney Kardashian Stays by His Side

Travis Barker says he underwent cubital tunnel release surgery after experiencing numbness in his arm, hand and fingers, adding that he hopes to resume drumming within weeks.

International Business Times UK

Woman orders a Whopper and a Whopper Jr. at a mall Burger King. Then she sees the $30 total and shows the camera the tray: ‘This is crazy’

She showed everything that came with it.

We Got This Covered

'I didn't know this place existed': Britney Spears enjoys family day at Dollywood

Britney Spears enjoyed a visit to Dollywood with her two sons - but admitted she hadn't been aware the theme park "existed" before their trip.

How Jim Bakker became the Johnny Carson of Christian TV

When I was researching my 2017 book, “PTL: The Rise and Fall of Jim and Tammy Faye Bakker’s Evangelical Empire,” I interviewed dozens of former staffers and supporters of PTL, the ministry, television and theme park empire that the Bakkers built starting in the 1970s.

The Conversation

Fourteen days free

Download the app

One app. One membership.
100+ trusted global sources.

Download on the AppStore

Get it on Google Play